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: terumo femoseal vascular closure systems
medical device manufacturer, terumo medical corporation, has issued a safety alert concerning its femoseal vascular closure systems [product reference code: c11202].
the manufacturer is initiating a voluntary recall of select production lots of femoseal vascular closure systems in response to an increase in device related malfunction complaints. specifically, after the deployment of the inner locking disc, complaints allege that the button will not spring back as intended, preventing the outer locking disc from deploying and completing the procedure. when this failure occurs, options for the clinician include manual compression or surgical cut down.
upon further review, devices associated with this complaint mode (approximately 1/600 per current complaint date) reflect the internal entrapment of the device’s suture assembly. suture entrapment prevents the proper actuation of the device to complete the surgical procedure. internal controls have been established in manufacturing to eliminate the potential for this defect.
product replacement is on-going.
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 22 august 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: terumo® advanced perfusion system 1, roller pump
medical device manufacturer, terumo® cardiovascular systems (cvs) corporation, has issued an urgent field safety notice concerning terumor advanced perfusion system 1.
the manufacturer has received reports of various roller pump malfunctions of the terumo® advanced perfusion system 1 that could result in the inability to use the pump and require the user to replace it with back-up equipment. the malfunctions included: unplanned pump stop,changes in pump speed and occlusion malfunctions. there are no known reports of serious patient injury as a result of these issues.
terumo cvs' evaluation and/or initial investigation has determined that there are likely multiple root causes for the failures. it has initiated further investigation to determine exact root cause. as an interim precaution, the manufacturer is informing affecting users the risks associated with these failures, reminding them of the relevant instructions in the operator's manual, and providing an addendum to the operator's manual with additional instructions to be used during set-up to prevent occlusion malfunctions.
according to the local supplier, the affected devices were not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 3 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: terumo® advanced perfusion system 1, central control monitor
medical device manufacturer, terumo® cardiovascular systems (cvs) corporation, has issued an urgent field safety notice concerning terumo® advanced perfusion system 1.
the manufacturer has received reports of the central control monitor (ccm) for terumo advanced perfusion system 1 losing partial or full functionality.
symptoms that have been associated with a malfunctioning ccm include: full or partial loss of display; loss of control functions; or an inability to distinguish various status, alert, or alarm conditions. in one report, the ccm emitted smoke. their preliminary investigation found the failures were due to design or supplier workmanship issues.
the probability of patient injury caused by this malfunction is low because all the primary functions and controls on the ccm can be maintained through the terumo system 1's local controls. there have been no reports of patient injury as a result of this issue. the manufacturer is providing an addendum to the operator's manual for terumo system 1 with instruction on what to do in the event of a ccm malfunction.
according to the local supplier, the affected devices were not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 3 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: terumo® advanced perfusion system 1, centrifugal system
medical device manufacturer, terumo® cardiovascular systems (cvs) corporation, has issued an urgent field safety notice concerning terumo® advanced perfusion system 1.
the manufacturer has received multiple reports since september 2008 of various malfunctions of the sarns™ centrifugal system for the terumo® advanced perfusion system 1 in which the user was unable to achieve or maintain the desired flow rate.
their investigation revealed that a number of root causes contributed to the failures. the probability of the malfunction occurring in the affected population is rare – less than 0.00318% of uses. the manufacturer is creating an addendum to the operator's manual for the terumo system 1 centrifugal system which includes the following:
updates the instructions for responding to drive motor failure.
reinforces the recommendation to have back-up equipment for the centrifugal system available during cardiopulmonary bypass.
recommends that users consider the use of a one-way valve to prevent retrograde flow in the arterial line of the cardiopulmonary bypass circuit.
according to the local supplier, the affected devices were not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 3 july 2012.
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.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: terumo® advanced perfusion system 1, battery
medical device manufacturer, terumo® cardiovascular systems (cvs) corporation, has issued an urgent field safety notice concerning terumo® advanced perfusion system 1.
the manufacturer has received multiple reports regarding battery capacity issues in which the terumo® advanced perfusion system 1 displayed some or all of the following symptoms:
the system displayed false information, indicating battery capacity (i.E. hours/minutes remaining) when the batteries have little or no remaining capacity
the system unexpectedly shut down without warning when running on battery power
batteries were completely depleted
batteries did not retain their charge as intended
terumo cvs' investigation determined that failure to properly charge and maintain the terumo system 1 batteries can cause the 'estimated battery time remaining' indicator (on the power sub tab of the ccm) to display more battery time than is actually available
the potential harm is exacerbated if the user believes the batteries are fully charged because the system falsely over-reports the available battery time. there have been no reports of patient injury as a result of this issue. the manufacturer is developing a field correction to prevent the ‘estimated battery time remaining’ indicator from falsely over-reporting available battery time.
according to the local supplier, the affected devices were not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 3 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: terumo® advanced perfusion system 1, electronic patient gas system
medical device manufacturer, terumo® cardiovascular systems (cvs) corporations, has issued an urgent field safety notice concerning terumo® advanced perfusion system 1.
the manufacturer has received reports of two instances where users were confused about the proper adjustment of the local control knobs of the electronic patient gas system on the terumo® advanced perfusion system 1.
their investigation revealed that the issue resulted from insufficient labeling on the local control knobs of the electronic patient gas system and a lack of sufficient information in the terumo system 1 operators manual. user confusion about adjustment of the local control knobs could result in a delay in detection and correction of incorrect gas composition to the patient. there have been no reports of patient injury as a result of this issue.
the manufacturer will provide additional labeling on the terumo system 1 electronic patient gas system local controls and provide more specific instructions in the operators manual through an addendum.
according to the local supplier, the affected devices were not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 3 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: vascutek biplex vascular grafts and biplex biovalsalva conduits (stentless and stented)
the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) posted a field safety notice (fsn) concerning biplex vascular grafts and biplex biovalsalva conduits (stentless and stented), manufactured by vascutek ltd.
vascutek issued a fsn to increase clinician awareness regarding bleeding, experienced by some customers when using biplex vascular grafts and biplex biovalsalva conduits. of total product sales, which includes biplex vascular grafts and biplex biovalsalva conduits (stentless and stented); field events of graft bleeding are recorded as 2.6%. of this 2.6 % total, 80% of reports are from one country, i.E. italy. in these cases, clinicians have experienced bleeding from graft suture holes and/or anastomoses requiring additional intervention e.G. resternotomy. bleeding and re-intervention to correct bleeding has occurred during or shortly after surgery.
according to the local supplier, the affected products were not distributed in hong kong.
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 products, please contact your supplier for necessary actions.
posted on 7 august 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: terumo anaconda one- lok bifurcate body and anaconda bifurcate body
medical device manufacturer, vascutek ltd, a terumo company, has issued a field safety notice concerning anaconda one-lok bifurcate body and anaconda bifurcate body. the affected catalogue numbers are as follows:
anaconda one-lok bifurcate body: olb21, olb23, olb25, olb28, olb30, olb32, olb34
anaconda bifurcate body: b19, b21, b23, b25, b28, b30, b32, b34
vascutek ltd has received three complaints (with an occurrence rate of 0.1%) where the release wire of an anaconda body delivery system has fractured following stent deployment. two of these three incidents resulted in conversion to open repair.
the voluntary recall addresses potential risks associated with the wire fracturing and the possibility of conversion to open repair.
according to the manufacturer, this is a potential failure mode of to delivery system and does not affect the safety or efficacy of the implantable stent. previously implanted stents are not affected by this voluntary recall.
furthermore, according to the manufacturer, there is no suggestion that patients already implanted with anaconda one- lok bifurcate body or anaconda bifuracte body are exposted to any raised level of risk.
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 22 october 2013.
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.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device removal: terumo level sensor ii pads
terumo cardiovascular systems (terumo cvs) issued an urgent product removal of level sensor ii pads. the removal followed an investigation about the reports of level sensor ii pads detaching from the surface of the venous reservoir. the affected products are of an older population that is labeled with a manufacture date but not an expiration date. they were shipped between december 28, 2000 and january 1, 2010. the adhesive is intended for use within two years of the date of manufacture, otherwise it may detach.
the detachment of the level sensor pad from the venous reservoir compromises the capabilities of the level detection system, preventing the ultrasonic level sensor from maintaining adequate contact with the reservoir. the risk caused by the detachment of the level sensor pad varies with the type of perfusion system that it is used with. in serious cases, it may cause interruption to blood flow due to unanticipated pump stop, which in turn, may lead to reduction in blood pressure and severe injury.
according to the local supplier, there is no record of distribution of the affected product in hong kong.
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
Field safety notice: sarns™ modular perfusion system 8000: cardioplegia monitor
terumo has issued an urgent medical device correction on sarns™ modular perfusion system 8000: cardioplegia monitor, a device that displays a various parameters including cardioplegia volume tracking. according to the manufacturer, only certain serial numbers are affected by this safety alert.
the manufacturer has received 12 reports that captioned device fails to track the cardioplegia delivery volume as needed due to the loss of communication between the monitor and the cardioplegia pump. the manufacturer revealed that the immediate and long term effects of this failure are minimal and there has been no report of patient injury as result of this issue.
to correct the issue, terumo will replace the software on all monitors in the affected devices. affected customer will be contacted and the correction action will be completed within 12 months.
>according to the local supplier, hong kong does not bare devices with the affected serial numbers.
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
Field safety notice: terumo cvs cdi blood parameter monitoring system 500
medical device manufacturer, terumo cardiovascular system (terumo cvs), has issued an urgent field safety notice concerning cdi blood parameter monitoring system 500 distributed during the period october 2009-may 2011.
during functional testing, terumo cvs identified a defective integrated circuit on the main circuit board in the cdi blood parameter monitoring system 500. this integrated circuit could potentially cause cdi system 500 not to function after a loss of power, either upon intentional power down or due to an unexpected power outage. in this case, the monitor would display error codes upon restart, and would not be useable. there have been no confirmed complaints from cdi system 500 users on this issue.
according to the local supplier, hk is not affected.
if you are in possession of the affected products, 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: terumo sarns modular perfusion system 8000
medical device manufacturer, terumo cardiovascular systems corporation (terumo cvs) has initiated a field safety corrective action concerning sarns modular perfusion system 8000.
terumo cvs has received multiple reports since 2007 of various malfunctions of the power distribution and battery back-up systems for the sarns modular perfusion system 8000. very few of the reports occurred during cardiopulmonary bypass; the majority of the malfunctions occurred during set-up or were reported during routine preventative maintenance.
the malfunctions can be broadly categorized as loss of wall (ac) power, battery back-up malfunction and battery status indicator malfunction. terumo cvs’ initial investigation found that the operator's manual for the sarns system 8000 does not provide sufficient instruction on how to respond to a flashing red indicator light and how to ensure the function of the battery back-up prior to each case. there were no known reports of patient injury as a result of these issues.
the manufacturer is informing sarns system 8000 users of the risks associated with these malfunctions and providing an addendum to inform the user with additional instructions.
according to the local supplier, the affected products were not distributed in hong kong.
if you are in possession of the product, please contact your supplier for necessary actions.
posted on 2 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.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: terumo cvs sarns disposable centrifugal pump
medical device manufacturer, terumo cardiovascular systems (cvs) corporation has issued a field safety notice concerning its sarns disposable centrifugal pumps.
the manufacturer has received complaints of sarns disposable centrifugal pumps leaking due to a crack in the molded separator.
the manufacturer’s investigation determined that two factors must be present to cause a leak in the molded separator:
degradation in the strength of the separator material: exposure to extremely low temperatures can degrade the strength of the separator’s polycarbonate resin.
contraction of two dissimilar materials: the polycarbonate separator and stainless steel bearing can contract at different rates while exposed to extremely low temperatures, potentially causing the white separator to crack. product was exposed to these temperatures in the course of transport during an unusually harsh winter. these temperatures were outside a clinically relevant operating range.
if a pump leaks during priming, the centrifugal pump can be changed out prior to initiating cardiopulmonary bypass (cpb) with no delays in the surgical procedure.
if a centrifugal pump leaks while the patient is on cpb, the manufacturer advises user to follow the instructions for use (ifu) and replace the centrifugal pump. in any time a centrifugal pump fails when being used as an arterial pump, arterial flow to the patient is interrupted during the change-out procedure. in addition, a stopped centrifugal pump can result in retrograde flow from the patient to the circuit.
potential patient impact includes air embolism, blood loss, infection and/or an interruption in the cardiopulmonary bypass support for an indeterminate amount of time.
in addition, replacing a centrifugal pump during cpb necessitates that the replacement device connections be made with wet connections which do not have the same security as a dry connection. this can increase the risk of a tubing disconnection.
the manufacturer advises users to stop using sarns disposable centrifugal pumps from the affected single, sterile centrifugal pump lots or cardiovascular procedure kit lots. the manufacturer will also replace or credit unused affected centrifugal pumps.
according to the local supplier, the affected products were not distributed in hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 25 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: ortho clinical diagnosticsortho biovue system cassettes
the medicines and healthcare products regulatory agency(mhra), united kingdom posted a field safety notice concerningortho biovue system cassettes, manufactured by ortho clinical diagnostics.
ortho clinical diagnostics has identified isolated occurrences of improperly positioned cassette labels for certain products.An investigation confirmed that the cause of the issue occurred on one of our three manufacturing lines following a particular sequence of events.The occurrence rate of the issue is very low.
the use of an affected multi-reagent cassette may lead to false negative or false positive results causing a potential misclassification of the patient or donor blood groups or incorrect antibody detection results. there is no risk associated with the use of an affected single-reagent cassette since all wells contain the same reagent.
the manufacturer advises users to
inspect all cassettes from the potentially affected lots remaining in facility prior to use, by referring to the ortho biovue system cassette inspection procedure for visual detailed instructions; and
do not use cassettes with an incorrectly positioned label and discard the affected cassette in accordance with local regulations.
according to the local supplier, the affected products were distributed in hong kong.
for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con287036
if you are in possession of the product, please contact your supplier for necessary actions.
posted on 9 july 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: ortho clinical diagnostics vitros 25-oh vitamin d total calibrators
medical device manufacturer, ortho clinical diagnostics, has issued a medical device safety alert concerning its vitros 25-oh vitamin d total calibrators [product code: 6842893; lot numbers: 0091 through 0235].
the manufacturer has found that the vitros immunodiagnostic product 25-oh vitamin d total calibrators, lots 0091 through 0235, used with vitros immunodiagnostic products 25-oh vitamin d total reagent packs, may generate negatively biased results
the manufacturer advises all affected users to immediately discard all current lots of vitros immunodiagnostic product 25-oh vitamin d total calibrators and reagent packs (lots 0200, 0210, 0220, 0230 and 0235). affected users are also instructed to review previously reported results generated using vitros immunodiagnostic product 25-oh vitamin d total calibrators, lots 0091 through 0235.
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 29 january 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: ortho clinical diagnostics calibration data module
medical device manufacturer, ortho clinical diagnostics, has issued a medical device safety alert concerning its calibration data module (cdm prom) [affected lot: 0168 catalogue number: 1999077]. a cdm prom is an electronic device that contains data required to perform various tests on the vitros dt60/dt60 ii chemistry systems.
according to the manufacturer, this product correction notification has been initiated due to an inability to calibrate or use vitros crsc dt slides, gen 82 when using cdm prom 0168. calibration data module (cdm prom) 0168 contains data that allows the use of new lots of vitros dt slides and vitros dt calibrator kits on vitros dt60/dt60 ii chemistry systems. this cdm prom was sent to all customers beginning in october 2013. the manufacturer has received complaints for the inability to calibrate or subsequently use vitros crsc dt slides, gen 82 after the installation of cdm prom 0168.
according to the local supplier, the affected products were not distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 07 february 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: ortho clinical diagnostics vitros chemistry products specialty diluent and vitros chemistry products fs diluent pack 3
medical device manufacturer, ortho clinical diagnostics, has issued a medical device safety alert concerning its vitros chemistry products specialty diluent lot f3168 (product code 8559825) & vitros chemistry products fs diluent pack 3 lot 01-3266 (product code 6801754).
the manufacturer confirmed reports of lower than expected c-reactive protein (crp) results when using the affected lots of vitros specialty diluent and vitros fs diluent pack 3 to dilute samples tested on vitros crp slides. when using the affected lots of diluent, results using vitros crp slides may be negatively biased by approximately 51% using a 3x dilution factor.
the manufacturer advises affected users to take the following actions:-
immediately discontinue using and discard all remaining inventory of vitros specialty diluent, lot f3168 and/or vitros fs diluent pack 3, lot 01-3266.
review previously reported results using the affected lots. discuss any concerns regarding previously reported results with their laboratory medical director or with the requesting physician.
according to the manufacturer, the affected products were not distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 28 mar 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: ortho clinical diagnostics vitros immunodiagnostic products nt-probnp calibrators, vitros immunodiagnostic products nt-probnp reagent packs
medical device manufacturer, ortho clinical diagnostics, has issued a medical device safety alert concerning its viitros immunodiagnostic products nt-probnp calibrators (product code 6802157; lot 1110) and vitros immunodiagnostic products nt-probnp reagent packs (product code 6802156; lot 1110).
during routine internal testing, the manufacturer identified potential for non-reproducible, higher than expected results that may exceed the decision thresholds for congestive heart failure (chf) when using vitros nt-probnp reagent packs, lot 1110. when using the affected lots of products, elevated results were observed across the measuring range of the assay (5.00 to 35,000 pg/ml and 0.590 to 4130 pmol/l). analysis determined that this issue may affect approximately 1 in 73 test results, or 1.37%.
the manufacturer advises affected users to take the following actions:-
immediately discontinue using and discard all remaining vitros nt-probnp calibrators and reagent packs, lot 1110.
review previously reported results using vitros nt-probnp reagent packs, lot 1110.
according to the manufacturer, the affected products were not distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 08 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: ortho clinical diagnostics vitros immunodiagnostic products tsh calibrators; vitros immunodiagnostic products tsh reagent packs
medical device manufacturer, ortho clinical diagnostics, has issued a field safety notice concerning vitros immunodiagnostic products tsh calibrators (with product code 1487289) and vitros immunodiagnostic products tsh reagent packs (with product code 1912997). the affected products have a lot number of 4540 and an expiry date of 11 feb 2015.
the manufacturer received complaints from some customers who were unable to generate a successful calibration using vitros tsh calibrators and reagent packs, lot 4540 on vitros 5600 and 3600 systems. the manufacturer has received no complaints of failed calibrations on the vitros eci/eciq system. furthermore, the manufacturer has confirmed that vitros tsh calibrators and reagent packs, lot 4540 may generate lower than expected calibrator level 1 signals on some vitros 5600 and vitros 3600 systems, resulting in a failed calibration due to an elevation in the ratio of signals for calibrator levels 1 and 2 (delta1).
if the laboratory has a vitros eci/eciq system, users may continue to use vitros tsh calibrators and reagent packs, lot 4540 on the vitros eci/eciq system. any remaining inventory of lot 4540 is recommended to be used on the vitros eci/eciq system only.
if the laboratory has a vitros 5600 and/or a vitros 3600 only:
- users who have successfully calibrated vitros tsh calibrators and reagent packs, lot 4540 may continue using the current inventory until they have received the new product, provided that the tsh quality control results are acceptable.
- to avoid experiencing this issue in the future, users should discontinue using and discard all vitros tsh calibrators and reagent packs, lot 4540 after receiving the new product.
according to the local supplier, the affected products were not distributed in hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 17 jul 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: ortho clinical diagnostics ortho vision analyzer and ortho vision max analyzer
the medicines and healthcare products regulatory agency (mhra) of the united kingdom has posted a medical device safety alert concerning ortho vision analyzer and ortho vision max analyzer, manufactured by ortho clinical diagnostics.
the affected devices are identified as follows:-
a) ortho vision analyzer for ortho biovue cassettes; b) ortho vision max analyzer for ortho biovue cassettes
product code: a) 6904579 and b) 6904578
software version: 3.6.0 and below
the manufacturer confirmed that if incubation time parameters are changed when creating a user defined protocol (udp) test, then the incubation time of the ortho test template and other udp tests created from the same test template may change. the system will update the incubation time with the latest selection for all udps that use the same template, and will also update the ortho test template, as described in the example below:
udp test 1 is defined with the ortho test 08 abscr surg poly, and the minimum incubation time parameter is set at the default time of 15 minutes.
an additional udp, udp test 2, is subsequently defined with the same ortho test 08 abscr surg poly, and the minimum incubation time is set to 30 minutes.
the minimum incubation time for udp test 1 and the template test ortho test 08 abscr surg poly is unexpectedly changed by the system software to the default time of 30 minutes (i.E., the minimum incubation time parameter of upd test 2). the user is not notified of the change.
the incubation time parameters will reset back to the values from the assay data disk (add) for the ortho test template and the associated udps will be reset to the original validated parameters during restart of the analyzer.
the unintentional change to the udp assay incubation time parameter on the ortho vision and vision max analyzer may cause over- or under-incubation for tests, potentially leading to false positive or false negative test results. the affected udp assays may include antibody screening and identification tests, dat, antigen typing, as well as ortho sera (igg) or other antisera tests.
affected users are instructed to take the following action:-
after adjusting the incubation time parameters of a udp test, make sure to restart the system prior to processing samples so that the incubation time parameters will reset back to the values from the assay data disk (add) for the ortho test template and the associated udps will be reset to the original validated parameters during restart of the analyzer.
this issue will be addressed in software version 4.8.0 (mod 16) that is targeted to be released by year end 2016.
according to the local supplier, the affected products are distributed in hong kong.
for details, please refer to the mhra website:
https://www.Gov.Uk/drug-device-alerts/field-safety-notices-28-november-2-december-2016
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 6 december 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.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: ortho clinical diagnostics vitros chemistry products dat performance verifiers
medical device manufacturer, ortho clinical diagnostics, has issued a medical device safety alert concerning its vitros chemistry products dat performance verifiers [product code (lot number): 6802327 (h5616); 6802328 (j5617); 6802329 (k5618); 6802330 (l5619); 6802331 (m5620)].
this notification provides information regarding lower than expected quality control (qc) results obtained for vitros benz reagent using the specific lots of vitros dat performance verifier listed above.
the manufacturer performed an investigation and determined that qc results for benz (only) were lower than expected when using the affected lots. data confirmed that the concentration of lormetazepam (benz) in the affected lots of vitros dat pvs has shown a decrease over time. there are reduced levels of lormetazepam when the controls were tested on a confirmatory method (i.E., gas chromatography/mass spectrometry). no other assays in the vitros dat performance verifiers are affected by this issue.
if the issue occurs, qc results for benz may be at or below ortho’s range of means as defined in the assay sheets. this issue may lead to an inability to verify calibration or cause failures in daily qc results.
according to the manufacturer, if the qc results using vitros dat performance verifiers are within the established ranges for each assay, it is acceptable to use the affected lots until a replacement order arrives.
according to the local supplier, 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 20 september 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: ortho-clinical diagnostics ortho bliss
medical device manufacturer, ortho-clinical diagnostics, has issued a medical device safety alert concerning its ortho bliss [product code: 707116; lot no.: 280397; quantity 4 x 50ml; expiry date: 06 aug 2015] due to the presence of mold particles (cladosporium species) in unopened vials of ortho bliss, lot 280397.
during a routine internal inspection, the manufacturer observed mold-like particles in four vials of ortho bliss, lot 280397, out of a total of 2400 vials (0.17%) that were inspected. testing performed by millipore (uk) ltd., the contract manufacturer, confirmed the presence of mold (cladosporium species) in these four vials of ortho bliss vials, lot 280397. testing conducted by millipore (uk) ltd. confirmed that vials of ortho bliss, lot 280397 containing mold continued to meet product performance specifications for potency, specificity, ph, conductivity, and osmolality.
according to the manufacturer, previously reported results obtained with ortho bliss, lot 280397 are acceptable, provided that the expected results were obtained during quality control testing. affected users can continue using the current inventory of ortho bliss, lot 280397 until they receive replacement products. results are acceptable, provided that they follow the ortho bliss instructions for use, specifically:
visually inspect all vials of ortho bliss prior to use. the ortho bliss instructions for use cautions against using the product if it is turbid or discolored.
perform quality control testing on each day of use. patient results are acceptable, provided that the expected results were obtained during quality control testing
upon receipt of the replacement products, affected users should discontinue using and discard all remaining vials of ortho bliss, lot 280397.
possible health hazards include rectal damage (necrosis/ perforation/ulceration or bleeding), expulsion of the device and/or leakage, fecal soiling of bed linen/incontinence pads leading to skin deterioration around the anus, peeling skin, and raw, irritated lesions due to skin contact with fecal matter. death may also occur. the manufacturer advises users to stop using and return the affected devices.
for details, please refer to the fda websites
according to the local supplier, the affected products were not distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 24 jun 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.