BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 1354165 · Received March 31, 2009

    Report

    Report Number
    6000001-2009-00288
    Event Type
    Malfunction
    Date Received
    March 31, 2009
    Date of Event
    March 1, 2009
    Report Date
    March 5, 2009
    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

    EVAL SUMMARY: THE REPORTED CONDITION OF "PHM KEYPAD INOPERABLE" WAS CONFIRMED AS THE OPEN AND STOP KEYS WERE NOT FUNCTIONING. INSPECTION OF THE PUMP REVEALED THE OPEN AND STOP KEYS THAT WERE NOT FUNCTIONING WAS CAUSED BY A FAULTY PUMP HEAD MODULE (PHM) KEYPAD. THE PHM KEYPAD WAS REPLACED ON THE PUMP TO CORRECT THIS CONDITION. THIS ISSUE IS BEING INVESTIGATED UNDER CAPA.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A PUMP WITH A "PHM KEYPAD INOPERABLE". THE CONDITION WAS CONFIRMED AS THE OPEN AND STOP KEYS WERE NOT FUNCTIONING. THE CONDITION OCCURRED DURING BIO-MED TESTING. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSPITAL REPRESENTATIVE. NO ADDITIONAL INFO IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1