BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1112744 · Received August 11, 2008

    Report

    Report Number
    1423500-2008-00739
    Event Type
    Malfunction
    Date Received
    August 11, 2008
    Date of Event
    July 22, 2008
    Report Date
    July 22, 2008
    Manufacturer
    KXBAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBLEM CASSETTES WERE DISCARDED AND ARE NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TECHNICAL SERVICE CENTER REGARDING SPLIT TUBING THAT WAS DISCOVERED ON THE CASSETTE DURING SET UP. THE PT (HP) WAS CONTACTED IN 2008, AND STATED THAT THERE WERE 2 CASSETTES THAT HAD SPLIT TUBING AND LEAKED FLUID. THE PROBLEM WAS IDENTIFIED DURING SET UP. THE HP DID NOT NOTICE ANY DAMAGE TO THE OUTER CASE AND STATED THE CASSETTE PACKAGING WAS INTACT. THE HP DOES NOT HAVE ANY PETS THAT WOULD HAVE ACCESS TO THE SUPPLIES. THE HC UNIT WAS OPERATIONAL. NO PT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT. RENAL PRODUCT SURVEILLANCE, QUALITY ENGINEERING, ALONG WITH PLANT MFG, WILL CONTINUE TO MONITOR THIS PRODUCT LINE. THIS COMPLAINT WAS REVIEWED AND APPROVED FOR CLOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG 78FKX FKX KXBAXTER HEALTHCARE H08B01055

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR