BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1234099 · Received November 19, 2008

    Report

    Report Number
    6000001-2007-03436
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    January 1, 2007
    Report Date
    January 9, 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 814:01 WAS CONFIRMED. INSPECTION OF THE DEVICE FOUND THAT THE CAUSE OF THE FAILURE CODE WAS DUE TO DEPLETED AND POTENTIALLY DAMAGED BATTERIES. THE BATTERIES WERE 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 WHICH WAS OPENED ON APRIL 1, 2005 AND CAPA WHICH WAS OPENED ON MARCH 20, 2006.

    Description of Event or Problem · 1

    THE FACILITY REPORTED TO CUSTOMER SERVICE A PUMP WITH FAILURE CODE 814:01. THIS FAILURE CODE OCCURRED BEFORE USE. 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 CX VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1