BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1832660 · Received September 13, 2010

    Report

    Report Number
    6000001-2007-01070
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    December 1, 2006
    Report Date
    December 1, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    CONTINUED ON H10
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).EVALUATION SUMMARY:THE REPORTED CONDITION OF THE PUMP NOT HOLDING A CHARGE WAS CONFIRMED. INSPECTION OF THE DEVICE FOUND THAT THIS WAS CAUSED BY FAILURE CODE 570:320:844:0000, WHICH WAS CAUSED BY DEPLETED BATTERIES, THEREFORE THE PUMP'S BATTERIES WERE REPLACED. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE. THIS ISSUE IS BEING INVESTIGATED UNDER CAPA, (B)(4).CONTINUED FROM H9:6000001-2/25/05-004-C6000001-12/13/05-019-C

    Description of Event or Problem · 1

    THE FACILITY REPORTED A PUMP WITH A BATTERY THAT WILL NOT HOLD A CHARGE. IT IS UNKNOWN WHEN THIS OCCURRED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSPITAL REPRESENTATIVE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    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