BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1951804 · Received January 6, 2011

    Report

    Report Number
    1423500-2011-00236
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 5, 2010
    Report Date
    December 14, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF AN OVERPRIME - LEAK OUT OF PATIENT LINE. THE COMPLAINT WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE AND NO ROOT CAUSE HAS BEEN IDENTIFIED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S QUALITY REVIEW.

    Description of Event or Problem · 1

    DURING A FOLLOW UP CALL FOR A RELATED COMPLAINT FILE, THE CARE GIVER (CG) REPORTED TO PRODUCT SURVEILLANCE THAT SHE DID NOT NOTICE ANY VISIBLE DAMAGE OR ABNORMALITIES WITH THE CASSETTE THAT WAS IN USE ; HOWEVER, DID NOTE THAT SOLUTION LEAKED OUT OF THE TOP OF THE PATIENT LINE. THE CG CONFIRMED THERE WAS NO LEAK IN THE CASSETTE. THE CG STATED SHE WAS ABLE TO RESUME THERAPY SUCCESSFULLY WITH NEW SUPPLIES. THE CG REPORTED NO ADVERSE EVENT RESULTING FROM THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR HOMECHOICE PRO APD SYSTEM (5C8310R)