BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1160336 · Received September 16, 2008

    Report

    Report Number
    6000001-2007-03285
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    December 1, 2006
    Report Date
    December 27, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    CONTINUED ON H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED CONDITION OF A FAILED PUMP WAS CONFIRMED. DURING INSPECTION OF THE DEVICE FAILURE CODE 570:320:844:0000 WAS FOUND. INSPECTION OF THE DEVICE FOUND THAT THE FAILURE CODE AND REPORTED CONDITION WAS DUE TO DEPLETED AND POTENTIALLY DAMAGE 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.

    Description of Event or Problem · 1

    THE FACILITY REPORTED TO CUSTOMER SERVICE A FAILED PUMP. IT IS UNKNOWN WHEN THIS EVENT 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 CX VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1