BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1234124 · Received November 19, 2008

    Report

    Report Number
    6000001-2007-03330
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    January 22, 2007
    Report Date
    January 22, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    CONTINUED ON H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: FAILURE CODE 570 WAS CONFIRMED IN THE EVENT HISTORY. FAILURE CODE 570 IS CAUSED BY LOW BATTERY VOLTAGE. INSPECTION OF THE DEVICE FOUND THAT THE PUMP'S BATTERIES WERE DEPLETED AND POTENTIALLY DAMAGED AND THEREFORE REPLACED. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE. THIS ISSUE IS CURRENTLY BEING INVESTIGATED UNDER CAPA.

    Description of Event or Problem · 1

    DURING SERVICE BY BAXTER, THE INFUSION PUMP WAS FOUND TO CONTAIN FAILURE CODE 570. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION OR CONTACT WAS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1