BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 1832697 · Received September 13, 2010

    Report

    Report Number
    6000001-2007-00272
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    December 8, 2006
    Report Date
    December 8, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    CONTINUED ON H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).EVALUATION SUMMARY:THE REPORTED CONDITION OF FAIL CODE 814:01 WAS CONFIRMED. THIS FAILURE WAS CAUSED BY DEPLETED BATTERIES. THE BATTERIES WERE REPLACED. THIS ISSUE OF FAIL CODE 814:01 IS CURRENTLY BEING INVESTIGATED UNDER MDQ-CAPA-(B)(4). THE ISSUE OF DEPLETED BATTERIES IS BEING INVESTIGATED UNDER MDQ-CAPA-(B)(4). REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE. (B)(4).

    Description of Event or Problem · 1

    THE FACILITY RETURNED THE DEVICE FOR SERVICE. DURING SERVICE, THE BAXTER REPAIR TECHNICIAN REPORTED FAIL CODE 814:01. 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 VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1