BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1345426 · Received January 20, 2009

    Report

    Report Number
    6000001-2009-00030
    Event Type
    Malfunction
    Date Received
    January 20, 2009
    Date of Event
    November 1, 2008
    Report Date
    November 12, 2008
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED CONDITION OF THE PHM CONTROLS INOPERATIVE WAS CONFIRMED. INSPECTION OF THE PUMP REVEALED THE PUMP HEAD MODULE (PHM) CONTROLS INOPERATIVE WAS CAUSED BY THE OPEN AND STOP BUTTONS ON THE FAULTY KEYPAD NOT WORKING. THE KEYPAD WAS REPLACED IN THE PHM ON THE PUMP TO CORRECT THIS CONDITION. THIS ISSUE IS BEING INVESTIGATED.

    Description of Event or Problem · 1

    THE BAXTER TECH REPORTED A PUMP WITH PUMP HEAD MODULE (PHM) CONTROLS INOPERATIVE FOR THE FACILITY. THE CONDITION OCCURRED DURING BIO-MED TESTING. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSP REP. NO ADDITIONAL INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CX VOLUMETRIC INFUSION PUMP 80FRN FRN BAXTER HEALTHCARE PTE. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1