BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1212925 · Received October 29, 2008

    Report

    Report Number
    6000001-2007-88987
    Event Type
    Malfunction
    Date Received
    October 29, 2008
    Date of Event
    July 2, 2007
    Report Date
    July 2, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    PMA / PMN Number
    K010566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM THE FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA JULY 25, 2007. EVALUATION SUMMARY: EVALUATION WAS PERFORMED AND THE CONDITION WAS CONFIRMED. INSPECTION OF THE DEVICE REVEALED THE CONDITION WAS DUE TO A DEFECTIVE USER INTERFACE MODULE PRINTED CIRCUIT BOARD (UIM PCB). THE UIM PCB WAS REPLACED IN THE PUMP TO CORRECT THIS CONDITION. THE PUMP WAS RE-EVALUATED, TESTED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A PUMP THAT FROZE UP DURING USE, UNABLE TO POWER OFF. THE FAILURE OCCURRED DURING PATIENT INFUSION. 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 80FRN FRN BAXTER HEALTHCARE PTE. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1