BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 1023920 · Received April 4, 2008

    Report

    Report Number
    6000001-2007-01905
    Event Type
    Malfunction
    Date Received
    April 4, 2008
    Date of Event
    December 1, 2006
    Report Date
    December 26, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE CONDITION OF FAIL CODE 812:02 WAS CONFIRMED IN THE EVENT HISTORY. CORROSION ON PUMP HEAD MODULE PRINTED CIRCUIT BOARD AT R131 AND C66 CAUSED THIS FAIL CODE. THE PUMP HEAD MODULE ASSEMBLY WAS REPLACED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED FAILURE CODE 812:02. INFORMATION WAS NOT PROVIDED REGARDING WHETHER OR NOT THE FAILURE OCCURED DURING A PATIENT INFUSION. THE HOSPITAL REPRESENTATIVE STATED THAT THERE WER NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION. 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.

    Patients

    Seq Age Sex Outcome Treatment
    1