BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2393705 · Received January 2, 2012

    Report

    Report Number
    6000001-2011-43093
    Event Type
    Malfunction
    Date Received
    January 2, 2012
    Date of Event
    December 1, 2011
    Report Date
    December 1, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE CONDITION WAS CONFIRMED BY SERVICE. THIS COMPLAINT IS AN ANCILLARY SERVICE EVENT OPENED DURING INVESTIGATION OF (B)(4). THE CAUSE WAS DETERMINED TO BE A CRACKED PUMPHEAD MODULE (PHM) HOUSING ON CHANNEL B. TO CORRECT THE CONDITION, THE PHM ON CHANNEL B WAS REPLACED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    DURING PRODUCT EVALUATION BY A BAXTER SERVICE TECHNICIAN, A COLLEAGUE INFUSION PUMP WAS FOUND TO HAVE A CRACKED PUMPHEAD MODULE (PHM) HOUSING ON CHANNEL B. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. THIS WAS NOT REPORTED BY THE CUSTOMER. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THIS EVENT. THIS INVOLVED AN UNREMEDIATED COLLEAGUE INFUSION PUMP WITH USER INTERFACE MODULE MASTER SOFTWARE VERSION 5.04.00. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1