BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CXE VOLUMETRIC INFUSION PUMP SINGLE CHANNEL RECERT

    MDR report key: 1871691 · Received October 15, 2010

    Report

    Report Number
    6000001-2010-04074
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 24, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 12:323:1024:0023 WAS CONFIRMED IN THE PUMP'S EVENT HISTORY BUT NOT DUPLICATED DURING PRODUCT EVALUATION. THE PUMP'S AIR IN LINE (AIL) PRINTED CIRCUIT BOARD (PCB) WAS TESTED AND FOUND TO BE WITHIN SPECIFICATIONS. THEREFORE, NO ASSIGNABLE CAUSE WAS PROVIDED DURING PRODUCT EVALUATION. HOWEVER, THE AIL PCB WAS REPLACED AS A PRECAUTION. ADDITIONALLY, THE EVENT OCCURRED ON (B)(6) 2010, PER THE EVENT HISTORY REVIEW, AS OPPOSED TO THE REPORTED OCCURRENCE DATE OF (B)(6) 2010. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 12:323:1024:0023. ACCORDING TO THE FACILITY, IT IS UNKNOWN WHEN OR IN WHICH CARE AREA THIS EVENT OCCURRED. UPON REVIEWING THE PUMP'S EVENT HISTORY, BAXTER QUALITY ENGINEERING DISCOVERED THIS EVENT INTERRUPTED DELIVERY. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 6.13.90.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CXE VOLUMETRIC INFUSION PUMP SINGLE CHANNEL RECERT PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1