Data from Singapore is current through September 2018. All of the data comes from the Health Sciences Authority (HSA), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Singapore.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: spacelabs healthcare arkon anesthesia delivery system
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning arkon anesthesia delivery system [model number: 99999 (230 vac versions)], manufactured by spacelabs healthcare.
the manufacturer has received two reports of the arkon transformer inrush pcba (pn: 670-1624-00) failing prematurely and causing loss of power on all auxiliary power outlets. the failure mode requires the cumulative auxiliary power outlet load to be in excess of 200 watts. if the inrush pcba fails, anesthesia monitoring, alarming and ventilation delivery will not be affected.
according to the manufacturer, the potential risk is that devices which do not have battery backup and that are plugged into an auxiliary outlet may lose power.
the manufacturer advises affected users to weigh the benefits versus the risks as well as ability to deploy alternative devices when deciding whether or not to continue to use the system. if users continue to use the affected system, the manufacturer advises the following:
keep the total load on the arkon auxiliary outlets below 200 watts cumulatively.
if the cumulative load exceeds 200 watts, plug the device(s) into another supply such as provided in the wall outlets.
the manufacturer would replace the affected transformer inrush pcba.
for details, please refer to the mhra website:https://www.Gov.Uk/government/publications/safety-information-from-manufacturers-field-safety-notices/field-safety-notices-21-to-25-september-2015
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 29 september 2015.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: spacelabs arkon anesthesia delivery system with version 2.0 software
the united states food and drug administration (fda) has issued a medical device safety alert concerning arkon anesthesia delivery system with version 2.0 software, manufactured by spacelabs healthcare ltd. the affected products were manufactured and distributed from 18 march 2013 through 17 june 2013. the affected serial numbers include arkn-000011, arkn-000016, arkn-000017, arkn-000019, arkn-000020, arkn-000021, arkn-000022, arkn-000023, arkn-000024, arkn-000025, arkn-000026, arkn-000027, arkn-000028, arkn-000029, arkn-000030, and arkn-000031.
the manufacturer is recalling the affected products due to a software defect. this software issue may cause the system to stop working and require manual ventilation of patients. in addition, if a cell phone or other usb device is plugged into one of the four usb ports for charging, this may also cause the system to stop working.
this defect may cause serious adverse health consequences, including hypoxemia and death. the manufacturer received one report related to the software defect. there has been no injuries or deaths associated with this malfunction.
the manufacturer will provide software update installation to the affected users to resolve this issue. until the software updates are installed, the manufacturer provided the following recommendations for users of the affected products:
if users continue to use the arkon anesthesia system, the manufacturer recommends users not to save spirometry loops until the manufacturer has remedied the software defect. the error is triggered by the combination of a spirometry loop save and a change in waveform configuration.
users are advised not to use the usb ports until after the arkon software is updated.
if the error does occur, the user will hear a buzzer and a warning icon will appear on the main display screen. the user should switch to emergency oxygen and manually ventilate the patient until such time as users can safely remove the system from patient use.
if users cycle power, the system will reboot in roughly 3 minutes and recover from the above software anomaly and mechanical ventilation can continue.
for details, please refer to fda websites:http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm393536.Htm
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 17 april 2014.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: spacelabs anesthesia workstations and service kits
the u.S. food and drug administration (fda) posted a medical device safety alert concerning bleasesirius anesthesia workstation, bleasefocus anesthesia workstation, and cas i/ii absorber contained in service kits part number 12200902, 050-0659-00, and 050-0901-00, and any workstation installed with the cas i/ii absorber, manufactured by spacelabs medical. these products were manufactured and distributed from 31 oct 2012 to 15 jan 2013.
there is a defect in cas i/ii absorbers in the spacelabs anesthesia workstations and service kits that may cause a condition leading to an increase in the carbon dioxide concentration within the inhaled gas being delivered to the patient.
until spacelabs replaces the affected product, the manufacturer advises customers to:
immediately cease use of bleasesirius and bleasefocus anesthesia workstations shipped after 31 oct 2012.
immediately cease use of service kits part number 12200902, 050-0659-00 and 050-0901-00 and any workstation containing a cas i/ii absorber from a service kit.
for details, please refer to fda websites
http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/
ucm345368.Htm
http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm345346.Htm
if you are in possession of the product, please contact your supplier for necessary actions.
posted on 27 march 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Mhra field safety notice: spacelabs healthcare hook-up kits containing non-sterile alcohol prep pads
the medicines and healthcare products regulatory agencies (mhra), united kingdom has issued a field safety notice on spacelabs healthcare’s hook-up kits containing non-sterile alcohol prep pads.
spacelabs healthcare reported that non-sterile alcohol prep pads that contained in some of their hook-up kits, may have the presence of a bacterium, bacillus cereus, which could lead to life-threatening infection.
spacelabs healthcare suggests the users to stop using these alcohol prep pads immediately and dispose them according to hospital or clinic protocol.
for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm
if you are in possession of the affected product, please contact your supplier for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: ossur female adapters on prosthetic feet
medical device manufacturer, ossur, has issued a medical device safety alert concerning its female adapters on prosthetic feet. the affected devices are identified as follow:
talux, vari-flex, vari-flex xc, re-flex shock, re-flex rotate
cat 7 sizes 28 – 30; cat 8 sizes 25 – 30; cat 9 all sizes
flex-foot assure, balance foot j
cat 4 size 30; cat 5 all sizes
the manufacturer’s recent findings suggest that non-össur female mating adapters connected to össur ankle male pyramids have caused early failure of the male pyramid connector. this is due to incompatible geometry of the female mating adapters used and/ or improper set up of the prosthesis. affected users are advised to follow proper set-up procedure according to the instructions for use.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 16 july 2015.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: owen mumford autopen, autopen 24, densupen and autopen 3ml for teriparatide
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning autopen classic, autopen 24, densupen and autopen 3ml for teriparatide manufactured by owen mumford ltd. the affected product codes are an3800, an3810, an4200, an4210, an1281 and an1251.
according to the manufacturer, a proportion of devices from the lot codes listed in the field safety notice have a potential mechanical fault. the fault presents itself in the following ways:
a) a dose may be dialled-up but the dose selector will not hold that dose and instead will spin straight back to zero.
b) the dose may be dialled-up and the dose selector will hold the dose momentarily, but will then spin back to zero.
this potential risks to patient are:
a) the patient will not be able to use the pen, no dose can be delivered.
b) the patient may only receive a partial dose and will not know how much insulin has been delivered.
the affected products are being recalled.
for details, please refer to the following link:
http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con484997
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 16 december 2014.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Field safety notice: pace medical micro-pace™ dual-chamber temporary cardiac pacemaker, ref 4580
it has come to our attention that medical device manufacturer, pace medical, inc. has initiated a field safety corrective action concerning micro-pace™ dual-chamber temporary cardiac pacemaker, ref 4580.
the manufacturer has observed a small population of ref 4580 in which a component has not performed as well as expected. it has been reported to the manufacturer that some users of the device have encountered the failure of a mosfet which can affect output of the device. typical failure has been seen where output has been compromised on either the atrial or ventricular channel of the device. after reviewing two recent incident reports and following to “bench testing” of the device, the manufacturer has decided to make a voluntary, proactive decision to modify the product by changing a mosfet component.
according to the manufacturer, the affected product is not distributed in hong kong.
if you are in possession of the product, please contact your supplier for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: pace medical micro-pace™ dual-chamber temporary cardiac pacemaker, ref 4580
it has come to our attention that medical device manufacturer, pace medical, inc. has initiated a field safety corrective action concerning micro-pace™ dual-chamber temporary cardiac pacemaker, ref 4580.
the manufacturer has had isolated reports of intermittent sensing issues with the affected product. under some circumstances, the affected device would fail to resume nominal sense operation once the programmed rate was lowered or became lower than the patients intrinsic rate. this was determined to be associated with depolarization of the regions surrounding the patient leads. with higher lead impedances the region surrounding the patient lead would take longer than expected to depolarize. this resulted in an extended offset period, which interfered with the device’s differential sense input amplifier. decreasing the device’s input impedance to 10k solved the depolarization effect allowing nominal sense operation with maximal rates and programmed outputs. a simple hardware change eliminates the potential for this occurrence.
the manufacturer advised users that:
they should return the affected product for complimentary upgrade.
they may use the device while scheduling product return; however it is recommended that patients are monitored while the device is in use and that the device is not used with patients with “heart wires” until the modification has been made to the device.
if you are in possession of the product, please contact your supplier for necessary actions.
posted on 6 july 2012.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: pace medical micro-pace 4580
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning micro-pace 4580, manufactured by pace medical, inc.
pace medical has observed in the ref 4580 that in a specific use of the device the defibrillation protection circuitry may not function as well as intended. if the device is used on a patient, with heart wires and the patient’s heart is defibrillated directly on the heart, there may be a chance that the device will be damaged from the defibrillation output current.
the manufacturer has designed and validated a new defibrillation protection circuit which will eliminate the potential for this to occur. furthermore, it advised that:
users should return the affected device for a complimentary upgrade.
the device should not be used in cardiac surgical theaters where heart wires are used and defibrillation is applied directly to the heart tissue.
ref 4580 can be used in other procedures while scheduling product return, but patients should be monitored while the device is in use and a backup device should be on hand.
for details, please refer to the following mhra website:
http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con185136
if you are in possession of the product, please contact your supplier for necessary actions.
posted on 25 september 2012.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: pace medical temporary pacemakers and pacing system analysers
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device alert (mda) concerning temporary pacemakers and pacing system analysers, manufactured by pace medical inc.
in april 2014, the subcontractor of the manufacturer was audited by its notified body, with the regulatory agency present as the observer. the audit found significant quality system failings relating to processes for complaint handling, post-market surveillance and vigilance, which included failures to implement corrective actions agreed at previous audits.
as a result of this, on 9 april, the notified body suspended the ec-certification issued to the manufacturer for all devices, except the pacing cables. any remaining pace medical devices purchased by distributors before this date can still be sold to uk hospitals. servicing of devices already in the field is unaffected by the suspension of the ec certificate.
according to the mhra mda, as the manufacturer only holds validation data to confirm compatibility of their own cables with their pacemakers, users are advised to continue to make a risk-based decision on the use of alternative, reusable or disposable cables or heart wires, based on availability and clinical need. furthermore, users should consult with the manufacturer or relevant distributors for further information on cable availability, where necessary. the manufacturer is working with its notified body to prepare a corrective action plan to address the identified issues. the notified body will need to complete follow-up audits of the manufacturer’s actions before the ec-certification can be restored.
for details, please refer to the following link:
http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-00536-2
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 16 may 2014.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: penumbra 3d revascularization device
the united states food and drug administration (fda) has issued a medical device safety alert concerning penumbra 3d revascularization device, manufactured by penumbra inc. [lot numbers: c00644, c00645, c00646, c00717; distribution dates: 15 may 2017 to 7 june 2017; manufacturing dates: 21 march 2017 to 28 april 2017]
the manufacturer is recalling the penumbra 3d revascularization device because there is a risk of the delivery wire breaking or separating during use. fractured pieces of the delivery wire could be left inside the patient’s brain bloodstream, and this or the attempts made to retrieve the fractured pieces, can make the stroke worse. this can also cause other serious adverse health consequences such as continued blockage of blood vessels, completion of the stroke, and death.
affected users are advised to identify and remove any affected 3d revascularization devices from inventory and quarantine.
for details, please refer to the fda websites:
https://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm567913.Htm
https://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm567990.Htm
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 24 july 2017.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: penumbra neuron max catheters
medical device manufacturer, penumbra inc., has issued a medical device safety alert concerning neuron max catheters. the affected catalogue numbers are as follows:
pnmd8f088804m - 8f 088 neuron max 088 delivery catheter 80/4 mp
pnmd8f088904m - 8f 088 neuron max 088 delivery catheter 90/4 mp
pnml6f088804m - 6f 088 neuron max long sheath 80/4 mp
pnml6f088904m - 6f 088 neuron max long sheath 90/4 mp
pnml6f0881004m - 6f 088 neuron max long sheath 100/4 mp
the manufacturer has recently identified that, for some neuron max catheters, it is possible for the packaging mandrel to remain within the catheter during removal. when this occurs, the catheter tip can be damaged. this is due to reduced adherence of the mandrel to the packaging card.
the manufacturer advises affected users to take the following preventive actions:
follow the product instructions for use and remove the device carefully
inspect the device prior use to detect any damage has occurred to the product during the removal from the packaging.
according to the local supplier, the affected products were distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 28 october 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: perkinelmer neobase non-derivatized assay solutions
medical device manufacturer, perkinelmer, has issued a medical device safety alert concerning its neobase non-derivatized assay solutions [product number: 3041-0020; lot number: 1063599401, 1063599501].
the manufacturer has become aware that some bottles used in the manufacturing of the neobase extraction solution (lots 634151 and 634247) and neobase flow solvent (lots 634152 and 634303), contained cardboard lint and red particles. bottles containing the aforementioned particles were used in the packaging of neobase non-derivatized assasy solutions kit lots 1063599401 and 1063599501. the particles can be visually detected by the human eye.
the manufacturer has become aware that some bottles used in the manufacturing of the neobase extraction solution (lots 634151 and 634247) and neobase flow solvent (lots 634152 and 634303), contained cardboard lint and red particles. bottles containing the aforementioned particles were used in the packaging of neobase non-derivatized assasy solutions kit lots 1063599401 and 1063599501. the particles can be visually detected by the human eye.
according to the manufacturer, the affected products are not distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 2 march 2015.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: hospira lifecare pca infusion system
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning lifecare pca infusion system, manufactured by hospira, inc.
the manufacturer has received customer reports related to improper use of the slide clamp when the syringe (vial) is manipulated, or when stopping the infusion during delivery of medication. failure to close the slide clamp whilst manipulating the syringe (vial) or stopping the infusion, may result in an over delivery of the medication being infused which has the potential to cause a life threatening/critical injury to the patient.
furthermore, the manufacturer advised users to follow the labelled instructions for the correct use of the slide clamp when manipulating the syringe (vial) or when stopping infusion during delivery of fluids. hospira is in the process of creating cautionary labels for the pca device, which will alert clinicians to close the slide clamp prior to handling the pca vial and to open the slide clamp before starting therapy. the manufacturer is also investigating whether a design improvement is feasible to further mitigate this risk.
for details, please refer to the following mhra website:
http://www.Mhra.Gov.Uk/safetyinformation/
safetywarningsalertsandrecalls/fieldsafetynotices/con184398
if you are in possession of the product, please contact your supplier for necessary actions.
posted on 11 september 2012.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: hospira plum a+ single channel family of infusers
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning plum a+ single channel family of infusers, manufactured by hospira, inc. the affected list numbers were 11005, 11971, 12391 and 20792.
hospira issued a field safety notice to inform users that the volume control knob on some plum a+ single channel infusers (located on the back of the infuser) may not function as described in the system operation manual; the direction for” loud” and “quiet” may be reversed. the manual indicates a clockwise rotation of the knob decreases the volume; however, on some of the devices the alarm volume increases when the knob is turned clockwise.
in the event the healthcare professional rotates the volume control knob in the direction described in the system operation manual, the audible tone may be the opposite of the desired audio level. while the device will continue to alarm with an audible one of at least 50 dba at the lowest level, inadvertently setting a low tone when a louder level is actually intended may result in an audible alarm that is more difficult to hear. if this happens, it is possible the clinician may not be alerted when an alarm condition occurs and an interruption in therapy may occur.
to correct the issue, hospira will update the system operating manual to clarify the instructions for setting the volume. furthermore, hospira will be creating a volume directional label as an additional improvement.
for details, please visit the following mhra website:
http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con199544
if you are in possession of the product, please contact your supplier for necessary actions.
posted on 6 november 2012.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: hospira venisystems blood bottle pumpset with cair clamp
it has come to our attention that medical device manufacturer, hospira, has initiated a field safety corrective action concerning venisystems blood bottle pumpset with cair clamp. the details of the affected devices are as follows:
list number: a) 04643-97-01; b) 12697-65; c) 12720-65
lot number: a) 040945g, 131335g; b) 281145h, 180015h, 040115h, 880485h, 782245h, 680585h; c) 161475h, 153405h, 032595h
there are increased complaints of backflow of fluid, incorrect assembly and no flow associated with the affected intravenous administration sets, which have resulted in retrograde flow. incorrect assembly of the bulb pump has the potential to prevent delivery of blood to the patient resulting in a delay of therapy. it may result in death or serious injury if a prolonged delay in the administration of life-sustaining blood products occurs. no reports of injury to patients have been received to date.
the manufacturer advises users not to use and immediately quarantine the affected products, and return them to the manufacturer. hospira is improving the manufacturing process to address incorrect assembly.
according to the local supplier, the affected products are not distributed in hong kong.
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 18 november 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: plum a+ infusion volumetric infusion pump
health canada has issued a medical device safety alert concerning plum a+ infusion volumetric infusion pump, manufactured by hospira.
the authority has recently received a report that a hospira plum a+ pump was found to have an incorrectly positioned part resulting in a free flow of iv fluid when the door was opened. as a result of this recent incident, healthcare professionals are reminded to ensure that tubing is clamped when the door of an infusion pump is opened to avoid a potential risk of unrestricted gravity flow. patients using these devices in a home setting should not stop using their infusion pump unless advised to do so by their healthcare provider.
for details, please refer to the health canada website:http://www.Healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2014/38391a-eng.Php
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 14 march 2014.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: hospira nonvented y-set
medical device manufacturer, hospira, has issued a medical device safety alert concerning its nonvented y-set for transurethral resection (list number: 06543-01). the impacted batches are 13106ns, 13170ns, 13251ns, 14261ns, 14262ns, 15139ns, 16117ns, 17131ns, 17132ns, 17184ns, 18110ns, 18111ns, 18182ns, 19133ns, 20122ns, 20123ns, 20124ns, 20205ns, 22146ns, 22147ns, 22148ns, 22149ns, 23103ns, 23104ns, 23105ns, 23106ns, 24156ns, 25130ns, 25131ns, 27109ns, 27253ns, 27286ns, 28136ns, 28137ns, 29094ns, 29095ns, 29096ns, 30194ns, 30195ns, 30196ns, 31042ns, 31043ns, 32229ns, 32230ns, 33138ns, 33139ns, 33140ns, 34286ns and 35117ns.
in the complaint review, the manufacturer has discovered the issue of incomplete sealing in the secondary package of the affected batches of devices. the issue occurred either because the sterile pack was not sealed properly or the tyvek cover sheet was not centered on the bottom tray of the pack, allowing openings at the edge of the sterile package.
the open packaging of the affected product may lead to loss of product sterility, delay in initiating therapy, introduction of infectious agent and particulate onto the surface of the irrigation set. up to date, the manufacturer did not receive any complaint or adverse reporting associated with the incomplete sealing of the package.
the manufacturer advises affected users not to use the package if it is not intact.
according to the manufacturer, the affected products were distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 17 april 2014.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: abbott acclaim infusion pumps and hospira acclaim encore infusion pumps
the united states food and drug administration (fda) has issued a medical device safety alert concerning abbott acclaim infusion pumps and hospira acclaim encore infusion pumps, manufactured by hospira, inc. the affected abbott acclaim infusion pumps, list number 12032, were manufactured from february 1998 to november 1998 and distributed from september 1998 through february 2004. the affected hospira acclaim encore infusion pump, list number 12237, were manufactured from february 1997 to february 2010 and distributed from july 1999 through november 2013.
the manufacturer has received customer reports of broken door assemblies on the abbott acclaim infusion pumps and the hospira acclaim encore infusion pumps. when the door is closed properly, it helps ensure that the tubing is seated properly to ensure appropriate flow of therapy to the patient. if the door assembly breaks, it may prevent the door from closing properly and an over-infusion or a delay of therapy may occur. if the door cannot be closed, the pump cannot be used which can result in a delay of therapy.
use of these affected products may cause serious adverse health consequences, including death.
the manufacturer recommends users to inspect each hospira/abbott acclaim encore infusion pump for door handle cracks, prior to programming a therapy, by following the steps mentioned in the alert.
after following the instructions, if the user determines that a pump has a door that does not close correctly or if free flow is detected while the administration set is in the pump with the door closed, the user should close the roller clamp, remove the pump from clinical service and contact the manufacturer.
for details, please refer to the following fda websites:
http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm395845.Htm
http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm395854.Htm
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 5 may 2014.
Czech data is current through July 2018. All of the data comes from the Czech Public Registry of Medical Devices, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and the Czech Republic.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: hospira gemstar power supply 3vdc
the united states food and drug administration (fda) posted a medical device safety alert concerning gemstar power supply, 3vdc, manufactured by hospira.The affected devices are identified as follows:
wall mount power supply [list number:13026-05]
desk top power supply [list number:13072-05]
according to the fda, the power supply may not properly deliver electric power to the gemstar infusion pump. if the power supply fails, planned infusion therapy may be delayed if a backup power supply is not used. the manufacturer received a total of 20 reported incidents including one report of smoke and found that the gemstar infusion pump was operating on battery power while connected to the 3vdc power supply. there were no reports of injuries or death.
the manufacturer advises users to take the following precaution:
avoid arcing, wiggling, or dropping the power supply on hard surfaces. doing so may result in internal damage that would stop the power supply from working.
affected users are advised to remove the power supply from service. according to the manufacturer, there is no need to return fully functional power supplies (unless they malfunction).
for details, please refer to the following fda websites:
http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm421951.Htm
http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm421946.Htm
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 6 november 2014.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: hospira q core’s sapphire infusion pumps
medical device manufacturer, hospira, has issued a medical device safety alert concerning q core’s sapphire infusion pumps (hospira list number: 163113601).
the manufacturer’s investigation and analysis has determined that with specific drug concentrations of iron sucrose (range of 0.7 to 2.8mg/ml, “concentration range”) the pump may misinterpret the iron sucrose solution as air rather than an opaque solution, resulting in the generation of a false air-in-line alarm.
risk to health is limited to a delay in the administration of iron sucrose infusion in the concentration range only. the issue, if occurs, is immediately apparent to the provider at the beginning of the treatment as an air-in-line alarm is generated, which does not allow the treatment to start. in addition, iron sucrose therapy is not used for acute treatment of anaemia, the effected of iron sucrose takes days to occur, and alternative delivery mechanism are readily available. thus the risks of delay in therapy of intravenous iron sucrose are remote.
according to the manufacturer, intensive research has not revealed any other medication which raises the same issue, i.E., this issue is unique for iron sucrose and no other drug. the software algorithms within the pump are being improved to restore the device to its original specifications, enabling consistent delivery of the aforementioned concentration of iron sucrose. this improvement will address the root cause and prevent the false alarms.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 24 may 2016.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: hospira mednet medication management suite
the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning hospira labelled mednet medication management suite – with plum 360 infusion system [(i) version 6.1; list number: 16037-75-01; (ii) version 6.21; list number: 16037-75-02], manufactured by hospira (now icu medical).
the manufacturer has identified issues with hospira labelled mednet medication management suite versions 6.1 and 6.21 when used with plum 360 drug library management that occur during an import of a plum 360 drug library.
the mednet meds 6.1 and 6.21 programs, under certain conditions, can change the piggyback medication entry set settings for existing defined medication entries. this includes (a) whether a medication may be piggybacked and (b) whether an infusion may be interrupted by a piggyback.
a change to a piggyback rule set could result in a delay initiating a therapy or interruption of an active infusion. this issue could also lead to mixing of two infusion solutions. if two mixed solutions are incompatible a particulate could result or, if during a transfusion, a blood clot could form in the administration set. in rare circumstances, these conditions could lead to serious adverse health consequences.
the manufacturer is advising users that the issue arises during an import of a plum 360 drug library. users who have performed an import of a plum 360 drug library or have the need to do so should refer to the information provided to customers to confirm if the drug library is affected during the import. a correction to the issues will be addressed in mednet version 6.3.
for details, please refer to the tga website:
http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2017-rn-01336-1
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 25 october 2017.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Field safety notice: hospira gemstar™ bolus cord used with gemstar™ pump
it has come to our attention that the health canada was aware of problems associated with the gemstar™ bolus cord, used with the gemstar™ pump manufactured by hospira inc.
post-market incident reports indicate that defects with these cords can lead to failure to deliver, intermittent operation, and unrequested bolus delivery. the gemstar™ pump has software controls that set a maximum allowable dosage and minimum lockout time. an audible chirp signals for every requested delivery and provides notification to the patient and attendant staff. these safety provisions help to mitigate the potential risk to the patient. the health canada has not received any reports of patient injury.
the manufacturer's preliminary investigation suggests that the cord may be damaged by the force applied to remove the cord from the base of the gemstar™ unit. this may lead to cracking and open circuits or short circuits.
if you are in possession of the product, please contact your supplier for necessary actions.