BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1832737 · Received September 13, 2010

    Report

    Report Number
    6000001-2007-02086
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    November 1, 2006
    Report Date
    November 30, 2006
    Manufacturer
    BAXTER HEALTHCARE (SG)
    Product Code
    FRN
    Removal / Correction Number
    CONTINUED ON H10
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).EVALUATION SUMMARY:EVALUATION WAS COMPLETED AND THE REPORTED CONDITION OF DEPLETED BATTERY WAS CONFIRMED. INSPECTION OF THE DEVICE REVEALED POTENTIALLY DAMAGED BATTERIES. THE MAIN BATTERIES AND THE BATTERY HARNESS WERE REPLACED AND THE BAXTER TECHNICIAN TESTED THE DEVICE. 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).

    Description of Event or Problem · 1

    THE FACILITY REPORTED AN INFUSION PUMP WITH A BATTERY DEPLETED CONDITION. INFORMATION WAS NOT PROVIDED REGARDING WHETHER OR NOT THE FAILURE OCCURRED DURING AN INFUSION. 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 (SG) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1