Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Side slits and hanging holes have been reported missing on the final red cell pack of some bottom and top (bat) systems.The slits cut into the cv1014 pack are used to store the crossmatch line ‘pig-tails’. the hanging loop is used during the inversion of the pack to run additive into the concentrate red cells. this recall action was undertaken prior to consultation with the tga.
Acción
Macopharma is advising users that systems that are found to be absent of side slits and hanging loops should not be used, and that pack traceability is reported to to Macopharma for packs that cannot be returned. This action has been closed-out on 16/09/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Johnson & johnson medical (jjm) is advising that the sterrad 100nx system requires a ctick label (rfid) be applied to comply with the australian communications and media authority (acma) spectrum licensing and ctick requirements.
Acción
Johnson & Johnson Medical will be attending all sites to place the required label on the affected devices. This action has been closed-out on 13/07/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
In december 2014 (tga ref: rc-2014-rn-01289-1), alere initiated a correction to inform users of the alere inratio system that patients with certain medical conditions should not be tested with the system due to the potential, in certain cases, of the alere inratio system to provide an inr result that was significantly lower than a result obtained using a laboratory inr system. alere has recently decided to remove the alere inratio system from the market and to discontinue manufacturing the product line. alere will continue manufacturing and distributing the alere inratio test strips for a period of time to allow patients to safely transition to another monitoring method.
Acción
Alere is advising customers to transition to an alternative method to perform PT/INR testing as soon as possible. Alternate methods may include a plasma-based laboratory INR method or monitoring with a point-of-care system from a different manufacturer. After transitioning onto another system, the Alere system and remaining test strips must be returned to Alere. Customers can continue to use the Alere INRatio System until users have transitioned, as long as patients adhere to the precautions and recommendations found in the 2014 Recall for Product Correction letter and the current product insert.
For further information, please see https://www.tga.gov.au/alert/alere-inratio-ptinr-monitor-system .
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Siemens has identified that contaminants in the form of biomass can develop in the cooling system of artis systems, which can result in damage to the pump system. the presence of contaminants in the tube cooling circuit could impair the performance of the pump. the tube assembly can become overheated so that no radiation can be released. there is a risk that an ongoing procedure cannot be continued, however, the probability of this occurring is unlikely.
Acción
Siemens is advising users that a technician will be installing an additional external filter in the cooling water circuit to prevent the failure of the pump system. A further correction will be implemented to prevent the development of biomass in the cooling circuit as a permanent correction. Siemens is advising that there is no requirement to re-examine patients.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Siemens has become aware that serial psa measurements at values <0.2ng/ml are being used to monitor patients for biochemical recurrence of prostate cancer post-radical prostatectomy. the risk to health is limited to scenarios where the threshold for biochemical recurrence is defined independent of the 2013 american urological association (aua) guidelines or 2015 european association of urology (eau) guidelines which define recurrence of prostate cancer as a detectable or rising psa value post-radical prostatectomy that is =0.2 ng/ml (ug/l) with a second confirmatory level of =0.2 ng/ml (ug/l). in scenarios, where clinicians use the psa assay in accordance with clinical guidelines for biochemical recurrence there is negligible risk to health.In a recent study, the limit of quantitation (loq) level for the advia centaur/xp/xpt psa assay was evaluated and determined to be 0.04 ng/ml at the level of 20% within laboratory precision. this applies to all lots of advia centaur psa.
Acción
Siemens is providing a letter to emphasize that PSA values should be interpreted in accordance with current clinical guidelines for defining biochemical recurrence following radical prostatectomy. The use of PSA thresholds < 0.2 ng/mL (ug/L) to identify biochemical recurrence of prostate cancer is not recommended. Where clinicians decide to use a PSA value <0.2 ng/mL (ug/L) as a threshold for identifying patients who may be experiencing biochemical recurrence, the potential exists for unnecessary follow-up &/or treatment for progression of residual disease. Any clinician choosing to use PSA in this manner should be aware of current clinical guidance & the limitations of PSA assays. Siemens is advising users to review the information with the lab's Medical Director. Siemens is not recommending a lab review of previously generated results; however, this is at the discretion of the lab.
For more information, please see https://www.tga.gov.au/alert/psa-assay-used-advia-centaur-systems . This action has been closed-out on 10/05/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
There has been an increase in the number of complaints regarding the “stapler firing failed” message for the xi stapler. all cases involving the complaints were completed minimally invasively. one complaint of partial fire resulted in a serious injury when a partial fire across an artery resulted in bleeding (1/12900 xi staple procedures = 0.01%), which was resolved through use of pressure, suture, and a clip.The failure message interrupts the stapler firing prior to completion of the full staple line. when this error occurs, the transection of tissue may be incomplete. in all cases formed staples precede the cut line however; there may be unformed staples at the end of the line. the knife blade could be exposed. while this message can occur with gray, white, blue, or green reloads, the greatest concern is with gray and white reloads, where a partial fire could potentially occur while transecting critical vascular structures such as pulmonary, renal or splenic vessels.
Acción
Device Technologies is advising users that In the event of the “Stapler Firing Failed” message, please note the following:
1. While the Stapler remains in the clamped state, it provides compression and tamponades the vasculature.
2. Surgeons should ensure hemostatic and leak control, particularly when around critical vessels with the gray or white reload, before releasing the Stapler from the structure.
3. After unclamping, a blade may be exposed; hence, surgeons should not manipulate tissue with the Stapler after the “Stapler Firing Failed” message occurs.
4. Bedside assistants should take care when removing the fired reload, as sharps hazards, such as potentially exposed knife and unformed staples, may be present.
A software correction has been completed as a permanent correction. This action has been closed-out on 03/02/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Biomérieux has been alerted via a european committee on antimicrobial susceptibility testing (eucast) warning letter about potential underestimation of the minimum inhibitory concentration (mic) values for enterobacteriaceae and acinetobacter when using the etest colistin gradient test. there is potential to obtain false susceptible results.Biomérieux have initiated a complaint investigation. the investigations are on-going, with the following identified to date:- etest colistin performance depends on the mueller hinton agar plate used. - for enterobacteriaceae strains, the performance conforms if used in conjunction with the mhe agar (from biomérieux) with a good concordance rate compared to broth-micro dilution method.- there is a potential of false susceptible results on etest colistin with some mueller hinton agar (except with the mhe agar from biomérieux for the enterobacteriaceae strains).
Acción
bioMérieux is advising users that for Enterobacteriaceae strains, to can continue to use Etest COLISTIN for diagnostic purposes, only if it is used with MH-E agar (Mueller Hinton-E agar from bioMérieux Ref. 413822-or the soon to be launched 04091 MHE agar in October 2016)). If not, or if strains other than Enterobacteriaceae are tested, bioMérieux recommend users restrict its use to epidemiological surveys.
Among tests previously performed, it is recommended users identify any possible false Susceptible results, analyse the related risks and determine appropriate actions if relevant.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Zimmer biomet has initiated this action following an investigation which identified a defect with the acda 30 ml vial known as a split finish that could compromise product sterility. split finishes occur during the glass bottle manufacturing process. the data shows that the risk of a sterility breach is rare <1% and the risk of injury to patients is remote <0.1%. use may result in an infection. there have been no reported complaints to date.
Acción
Zimmer Biomet is advising users inspect and quarantine affected stock for return. This action has been closed-out on 02/03/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Cell marque has become aware certain lots of the rabbit monoclonal antibody exhibit an unacceptable immunohistochemistry (ihc ) test result. an investigation was undertaken which showed that lots 1335409a to 1335409f may exhibit a false negative result. false negative results are readily detected when appropriate tissue controls are used during testing. the manufacturer recommends the use of proper controls when performing ihc staining to detect this issue.
Acción
Abacus ALS is advising users to destroy any remaining kits of the affected lots. Affected product will be replaced with unaffected kits or credit issued. This action has been closed-out on 02/03/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
It has been reported to amplitude that sealing of some pouches is not as resistant as intended and could compromise their integrity, resulting in non-sterile devices. this may increase the risk of post-operative infection and may lead to an increased surgical time to locate an alternative device.
Acción
Amplitude is advising users to inspect stock and quarantine the affected batches for return. This action has been closed-out on 10/05/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Hill-rom has received one complaint where the ceiling bracket 71 has been shipped with an increased size of the center hole.A potentially hazardous situation exists if the ceiling bracket 71 with a larger center hole is used for a concrete ceiling installation since a m8 screw and washer will be used. analysis has shown that if the bracket is mounted with a m8 screw and washer in a concrete ceiling ultra system installation (maximum load of 400 – 500 kg) there is a safety hazard associated with the installation that could potentially cause the system to fall.
Acción
Hill-Rom is advising the distributor to inspect stock and quarantine the affected brackets for return. All the affected stock is with the distributor. This action has been closed-out on 10/05/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
This action has been undertaken to inform users with important information regarding the potential for vascular trauma with the use of the medtronic enveo r dcs. while the reports of vascular trauma received by medtronic have been infrequent - 39 events per 24,012 sales, they have included 19 deaths. medtronic’s observed rate for vascular trauma is lower than the tvt registry reports in the journal of the american college of cardiology (holmes, et al), which highlighted annular dissection and aortic disruption rates of 0.2% and 0.4% respectively. (while this data is not provided for the purpose of direct comparison of the incidence of vascular trauma with the use of the enveo r dcs due to differences in the event definitions and data collection methods, this data does provide relevant context for the observed incident rate). the tga is continuing its review of the issue together with medtronic and further communication on this matter may be provided at a later stage if needed.
Acción
Medtronic’s investigation identified multiple recommendations to reduce the rate of vascular trauma events which includes Physicians to consider complex anatomical configurations which could increase the risk of vascular trauma and death. Also, Physicians are advised during advancement of the delivery system, to magnify images sufficiently to enable visualisation of the capsule tip relative to the patient’s vasculature. If the delivery system tip is observed to bend in a different direction relative to the delivery system capsule, do not force passage. If significant resistance is encountered during advancement of the delivery system, do not force passage.
Use increased fluoroscopic magnification to assess the vasculature. More information about how to undertake patient selection and ways to progress the procedure in difficulty cases are provided in the letter to users. The Evolut R System Instructions for Use (IFU) will also be updated appropriately consistent with this action. This action has been closed-out on 16/05/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Boston scientific is undertaking a recall of the lotus valve system to remove units from the field that were manufactured prior to a component related change made in march 2016. this action is related to release mandrel breaks. the release mandrel is a component of the delivery system that is connected to the release pin which facilitates release of the valve from the delivery system.Products manufactured after the implementation of the component change are not impacted. boston scientific has not received any reports of release mandrel breaks for units built after this change. there is no impact to previously implanted devices since the issue only involves the delivery system and is not related to the performance of the implanted valve.
Acción
Boston Scientific is advising users to immediately discontinue use of and segregate affected product. Boston Scientific will arrange for the return of affected product. This action has been closedd-out on 16/02/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
If an affected patient monitor has been powered on continuously for several months, any displayed waveforms will contain out-dated data and therefore fail to reflect the patient’s current condition. even if out-dated waveforms are displayed as a result of this problem, the monitor’s alarms and numeric displays of vital signs will continue to function as specified and accurately reflect current patient data. the length of time that a monitor must be powered on before the problem occurs depends on the selected wave speed. it ranges from 102 days (@50 mm/s) to 820 days (@ 6,25 mm/s), and is approximately 205 days at the monitor’s default wave speed of 25 mm/s. the monitor must be powered off in order to avoid this problem. simply placing it in stand-by mode is not sufficient. please note that connected devices, such as central monitors continue to display the correct wave data.
Acción
Philips Healthcare is advising users to cycle the power on the affected devices on a monthly basis. A software upgrade will be implemented as a permanent correction.
Lebanese data is current through July 2018. All of the data comes from the Ministry of Public Health (Republic of Lebanon), 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 Lebanon.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Several batches of whipknot soft tissue cinch #5 sutures have a potential packaging issue. a smith & nephew internal evaluation revealed that the packaging design is insufficient to prevent a potential sterile barrier breach (pin hole) in the tyvek film of the pouch.If the sterile barrier breach is not detected prior to use, the compromised packaging could potentially lead to a non-sterile device entering the surgical field.To date, there have been no complaints or adverse events associated with this issue.
Acción
Smith & Nephew is advising users to immediately locate and quarantine affected devices. Affected stock will be replaced with unaffected product.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Hologic have identified that the lid of the atec canister may have cracks that are related to lost/no vacuum during an atec biopsy procedure.This issue can be discovered during the inspection of the canister during setup or via a system vacuum error when testing the eviva or atec biopsy needle. from customer complaints received to date there has not been any patient harm or other safety issue. however, the issue may prevent the system from enabling a procedure to continue.
Acción
Hologic is advising users to inspect stocks and quarantine all affected units. Hologic will arrange for affected stock to be recovered and replacement stock, or a credit note, to be issued.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Following a customer complaint about difficulties to interpret low viral load in whole blood samples, a biomérieux investigation showed that the sensitivity of the bk virus r-gene of 260 copies/ml (corresponding to 2.41 log10) claimed in the ifu for whole blood was not confirmed. a limit of detection (lod) experiment conducted with whole blood samples has led to a lod value of 1578 copies/ml (corresponding to 3.20 log10).The issue only impacts whole blood samples with a low viral load (260 to 1578 copies/ml), where amplification leads to creeping/flat amplification curves that are difficult to interpret. these problems of interpretation could lead to:- a false negative result,- a delayed result until a new run or a new test is performed.This issue has no impact on negative results or on high positive samples, as the amplification curves are well identified and also, does not impact the test when urine or plasma samples are used.
Acción
bioMérieux is advising users that the Limit of Detection (LOD) is 1578 copies/mL rather than 260 copies/mL for whole blood samples until the root cause is identified and corrected. In addition, bioMérieux is advising that in case of doubt or for attended low viral load samples, testing should be performed on plasma or urine samples instead whole blood samples.
Any concerns regarding previously reported results should be discussed with the Laboratory/Medical Director to determine the appropriate course of action. Following the completion of the manufacturer’s investigation, further actions may be undertaken.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Some mersilene tape product codes have been supplied with an incorrect instructions for use (ifu) insert. the product codes subject to this issue have being supplied with a mersilene suture ifu. the indications for mersilene suture are different from the indications for mersilene tape.
Acción
Johnson & Johnson are advising users to examine their inventory immediately to determine if they have affected product, and are providing the correct IFU for MERSILENE Tape.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Mölnlycke health care has become aware of situations where the umbilical clamp included in the procedurepak kits and trays may have been incorrectly used due to a lack of adequate instructions for use. if the clamp is used incorrectly i.E. both hooks in the clamp are not engaged, the clamp may reopen. if the clamp is not in place correctly when the umbilical cord has been cut, this can potentially lead to blood loss for the baby if not monitored regularly.The ifu will be improved to include further instruction to ensure correct usage of the clamps.
Acción
Mölnlycke Health Care is providing users with the correct instructions for the umbilical clamp. To ensure correct usage:
- Rotate the umbilical cord clamp with the open side of the lock towards you, so that you can see the locking hooks.
- Place the (thick) umbilical cord towards the ring end.
- Both hooks must be correctly positioned, check carefully that both hooks are securely clicked into place. Incorrect engagement of the hooks can cause the clamp to open. This action has been closed-out on 17/02/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
The image fusion functionality may display an incorrect calculation of standard uptake value (suv) when loading the presentation state of image for a previously calculated (and saved) region of interest (roi). this software defect could lead radiologists to base their diagnosis/report on erroneous anatomical measurement leading to incorrect medical treatment.To date, there have been no reports of patient incidents.
Acción
Emergo is advising users to confirm the software version installed on their IntelePACS system and if the version is 4-10-1 or earlier, to authorise Intelerad to install an upgrade to InteleViewer 4-11-1 or later. Users are advised to stop using the presentation states functionality of the Image Fusion module until they have InteleViewer 4-11-1 or later installed on their workstation. This action has been closed-out on 02/03/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
The centering hoops keep the head of the hydro lemaitre valvulotome centered in the vessel and prevents the valve-cutting blades from damaging the vessel wall. there have been reported issues of hoops failing to close when the device was actuated. in some cases, this issue has been discovered in-use. while no adverse events have been reported, there is the possibility that a malfunctioning device could damage the vessel upon withdrawal.
Acción
Emergo is advising users to locate, quarantine and return all affected product. Returned devices will be replaced with unaffected devices. This action has been closed-out on 02/03/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Beckman coulter has received and confirmed a report of a fire within the stainer module of a customer’s dxh slidemaker stainer. the fire was fully contained within the stainer module. the event was preceded by a significant increase in the frequency of the automatic top-off of the module’s methanol bath. users are being advised to discontinue use of the stainer module to reduce the potential for flammable liquids coming into contact with electrical components in the stainer module possibly causing a fire. beckman coulter is actively investigating the reported incident to determine the root cause, and define and implement required corrective and preventive actions.
Acción
Beckman Coulter is advising users to:
1. Immediately discontinue use of the Stainer module.
2. Drain all liquids from the Stainer module.
3. Follow the directions provided for placing the Stainer module in extended shutdown and disabling the Stainer.
Once the Stainer has been disabled, the Slidemaker module may be used to prepare slides for staining. Slides must be stained using an alternative method.
A Beckman Coulter service representative will schedule a visit to modify the Stainer module so that it remains disabled and cannot be used until further corrective action is implemented. This action has been closed-out on 02/03/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Nutricia australia has received reports from overseas where the air in line (ail) alarm functionality of the flocare infinity enteral feeding pump did not work as expected when used with a specialised modular feeding regimen.The air in line (ail) alarm functionality may not always work with mixed or reconstituted powdered nutrition. un-dissolved particles may accumulate in the enteral feeding line or form a film on the inner side of the tube, around the pump sensors, which may interfere with pump air detection algorithms. this may result in the delivery of (excess) air into the patient. if the ail alarm is used as an indicator that the reservoir is empty (therapy completed), follow up therapy may be delayed and may place critical care and volume sensitive patients at risk.To date, no ail alarm issues have been identified with the use of ready-made liquid feed tube nutrition.Nutricia is liaising with the tga to ascertain if further action needs to be undertaken.
Acción
Nutricia is advising that for patients where interruptions or delay in therapy could affect their health status, the AIL alarm should not be used to indicate end of dose and the DOSE setting of the Infinity pump must be used. It should be ensured that the volume of nutrition in the container is greater than the volume that is actually needed, i.e. more than the set DOSE to be administered, so as to avoid excessive air bubbles getting in the feeding line.
Nutricia is also advising users to ensure mixed or reconstituted powdered nutrition is prepared and dissolved properly to avoid particles or accumulation in the feeding set potentially hampering pump performance and a normal feeding regimen. Any nutrition added into the enteral feeding line must be of a homogeneous nature and should remain homogeneous.
Users must ensure that any substrate used is indicated as suitable for enteral tube feeding delivery (refer to instructions for use on nutrition / substrate added). Nutricia recommends that, where possible, patients use ready-made liquid tube nutrition, as this is developed for the delivery specifications of the pump.
For more information, please see https://www.tga.gov.au/alert/flocare-infinity-enteral-feeding-pumps . This action has been closed-out on 18/05/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Siemens has received reports of patients’ hair being caught in the e.Cam and symbia e patient bed up/down drive. siemens is reminding users of the patient positioning instructions for the e.Cam or symbia e systems. additionally, an enhancement kit that reduces the gap in the patient bed up/down drive has been designed and will be installed by siemens.
Acción
Siemens is reminding users of the positioning instructions for the e.cam and Symbia E systems that require operators to properly position the patient and observe the patient at all times. Siemens will be arranging for an enhancement kit to be installed by a Siemens service representative. This action has been closed-out on 23/06/2017.