BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1815986 · Received August 26, 2010

    Report

    Report Number
    6000001-2007-02134
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Date of Event
    December 22, 2006
    Report Date
    December 22, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    CONTINUED ON H10
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).EVALUATION SUMMARY:THE DEVICE EVALUATION WAS COMPLETED AND FAILURE CODE 570:320:844:000, FOUND TO BE DUE TO THE DEPLETED (DAMAGED) BATTERY CONDITION, WAS CONFIRMED. SERVICE INSTALLED NEW BATTERIES AND TESTED THE DEVICE. A REVIEW OF THE COMPLAINT HISTORY REVEALED SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT AND THE REPORTED ISSUE. THIS ISSUE IS BEING INVESTIGATED UNDER CAPA, (B)(4).

    Description of Event or Problem · 1

    THE DEVICE WAS RECEIVED FOR SERVICE. DURING SERVICE TESTING, FAILURE CODE 570:320:844:0000 WAS FOUND. ACCORDING TO THE HOSPITAL REPRESENTATIVE, THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1