BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1122124 · Received August 14, 2008

    Report

    Report Number
    1423500-2008-00744
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 23, 2008
    Report Date
    July 23, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE STILL UNAVAILABLE FOR EVALUATION AS OF 08/13/08. A FOLLOW UP MDR WILL BE SUBMITTED IF THE SAMPLES ARE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    BAXTER RENAL SERVIPAK HOME PATIENT SERVICES REPRESENTATIVE (HPSR) CALLED CORPORATE PRODUCT SURVEILLANCE (CPS) IN 2008 SAYING THAT SHE HAD RECEIVED A VOICE MESSAGE FROM THE PATIENT'S NURSE ON THE SAME DAY REGARDING AN UNSPECIFIED QUALITY OF HOMECHOICE CASSETTES IN WHICH HOLES ARE DETECTED. PER THE HPSR, PATIENT INVOLVEMENT WAS NOT SPECIFIED IN THE MESSAGE. THE NURSE WAS CONTACTED 12-AUG-2008, AND STATED THE PATIENT'S MOTHER WAS TO RETURN THE PROBLEM CASSETTES, BUT HAS NOT. THE NURSE WAS UNAWARE OF ANY PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. ATTEMPTS TO CONTACT THE PATIENT'S MOTHER DIRECTLY HAS BEEN UNSUCCESSFUL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1