BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1240863 · Received November 25, 2008

    Report

    Report Number
    6000001-2007-04119
    Event Type
    Malfunction
    Date Received
    November 25, 2008
    Date of Event
    February 3, 2007
    Report Date
    February 3, 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: THE CONDITION OF FAIL CODE 814:01 WAS OBSERVED IN THE EVENT HISTORY. THIS FAIL CODE WAS CAUSED BY DEPLETED BATTERIES. THE BATTERIES WERE REPLACED. THE ISSUE OF FAIL CODE 814:01 IS CURRENTLY BEING INVESTIGATED UNDER CAPA. THE ISSUE OF DEPLETED BATTERIES IS BEING INVESTIGATED UNDER CAPA. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE.

    Description of Event or Problem · 1

    THE FACILITY RETURNED THE DEVICE FOR SERVICE. DURING SERVICE THE BAXTER REPAIR TECHNICIAN NOTED FAIL CODE 814:01 IN THE EVENT HISTORY. THE HOSPITAL REPRESENTATIVE STATED THAT THERE HAVE BEEN NO REPORTS OF ANY PATIENT INCIDENT INVOLVING THIS PUMP. NO ADDITIONAL INFORMATION IS 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. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1