BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RE-MANUFACTURED IPUMP

    MDR report key: 1052870 · Received May 27, 2008

    Report

    Report Number
    6000001-2008-00344
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 2, 2008
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    PMA / PMN Number
    K052973
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE REPORTED CONDITION OF NO OPEN DOOR ALARM WAS CONFIRMED. THE REPORTED MALFUNCTION WAS CAUSED BY THE FAILURE OF THE REAR CASE SWITCH. THE REAR CASE ASSEMBLY WAS REPLACED, WHICH INCLUDES A NEW SWITCH, TO CORRECT THE REPORTED MALFUNCTION. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER ON 20 MAY 2008. THE MFG FACILITY HAS BEEN MADE AWARE OF THIS REPORT THROUGH BAXTER'S COMPLAINT MGMT TRACKING SYS. THE MFG FACILITY WILL CONTINUE TO MONITOR SIMILAR REPORTS FOR POSSIBLE TRENDS.

    Description of Event or Problem · 1

    THE FACILITY REP REPORTED A PUMP OBSERVED NOT RECOGNIZING THAT THE DOOR IS OPEN. THIS INCIDENT WAS OBSERVED BEFORE USE. NO PT INJURY OR MEDICAL INTERVENTION WAS REPORTED. ALTHOUGH BAXTER ATTEMPTED TO OBTAIN INFO, DETAILS WERE NOT AVAILABLE REGARDING ADD'L CONTACT INFO. THE DEVICE WAS SENT TO BAXTER FOR REPAIR AND/OR REFURBISHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RE-MANUFACTURED IPUMP 80FRN FRN BAXTER HEALTHCARE PTE. LTD. NA

    Patients

    Seq Age Sex Outcome Treatment
    1