Safety Alert for VOLUMETRIC INFUSION PUMP COLLEAGUE - ANVISA Record Nº 10068390320

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by BAXTER HOSPITALAR LTDA.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
  • Date
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Extra notes in the data
    The company informs you that your customers can perform a history event review of their pumps and any pump that has a history of error codes mentioned above must be removed from service. If you have questions about how to access the event history, check the attached Equipment Manual page or contact the Baxter Hospitalar Technical Service at 0800125522 option 3. All Colleague Infusion Pumps that are in the process of being evaluated by the Technical Service (Baxter) will have the verified event history, before returning to customers, for any fault codes listed above. If pumps are found that have any of these fault codes, this pump will not return to customers until corrective action is implemented. Baxter Hospitalar Ltda will retain shipments of new Colleague Infusion Pumps until this problem is resolved. If you have any questions about this, please contact your Baxter Hospitalar Ltda representative or call the service center at 0800 12 55 22 option 3 or email or ANVISA will be accompanying the actions that will be carried out through the company with regard to the entire process of correction and replacement of said product. - /// --- Brasília September 5, 2005 - 5:37 pm - / - Regarding the corrective field action that Baxter has been carrying out, the company informs:. Pumps active in Brazil: 4,761. Pumps already rated: 2.586. Pumps with indication of defects: 53 - (2.05%). Remainder: 2.175 Further informed that it sent communication to 136 clients, returned from 43 receipt indications, with a forecast for the end of the evaluations for September 30, 2005. - /// --- Brasilia September 12, 2005 - Letter Considering that the pumps, when presenting certain fault codes, immediately trigger the visual and audible alarms, alerting Nursing, and considering the initial tests showing a relatively low incidence of pumps that have been affected so far, we are reading the memory register (the pump stores the last 1000 events) to identify certain fault codes associated with that part. Once one of these codes has been identified, the pump is picked up (withdrawn and serviced). This action is being taken because the existence of any of these codes increases the possibility that it will occur again. To date, we have completed the verification in approximately 68% of installed pumps with an incidence of 1.7%. This incidence is in line with the average we have found in other countries. Our goal is to complete (100%) the checks in up to 3 weeks (late September). At the same time, a new electronic card and new software are being validated to replace the current ones. This action, board change and software, should be started as of December 2005.
  • Reason
    Problem with colleague infusion pump design. this problem in the design involves a timing circuit that can interrupt the internal communication in some equipment.
  • Action
    The company recommends that any pump that has the following error codes: 402,403, 532, 533, 534, 535, 599, 702, 703, 704, 720, 804:21, 804:22, 804:24, 804: 29, 804: 34, 804: 52, 804: 54, 804: 58 and 12: 303: xxx: 006, be withdrawn from service. Error codes 402, 403, 533, 535, and 599 were previously reported in Equipment Urgent Correction communication dated May 10, 2005. Colleague Infusion Pumps are designed to alarm, stop infusion, and display the error code on if an abnormal situation is detected. As this situation may occur during infusion, it is imperative that institutions have a contingency plan to mitigate any interruption during infusion therapy (eg, a reserve pump available). In addition, you should consider not using these pumps in a situation where pump replacement is not available or when a delay in therapy could be life threatening.


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