BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2120174 · Received June 10, 2011

    Report

    Report Number
    6000001-2011-07442
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 2, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Removal / Correction Number
    6000001-08/04/10-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH A DAMAGED BATTERY WAS CONFIRMED AND REPRODUCED DURING PRODUCT EVALUATION. THE ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM WAS DETERMINED TO BE DEPLETED BATTERIES RESULTING FROM USER ERROR. THE MAIN BATTERIES AND BATTERY HARNESS WERE REPLACED TO CORRECT THE REPORTED CONDITION. THE CORRECTION/REMOVAL REPORTING NUMBER SHOULD HAVE BEEN POPULATED IN THE INITIAL MDR.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED "DAMAGED BATTERY", ON A COLLEAGUE INFUSION PUMP, WHICH HAD THE POTENTIAL TO CAUSE AN INTERRUPTION OF 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 PRE P1.7 PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1