BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE INTEGRATED APD SETWITH CASSETTE 3-PRONG

    MDR report key: 1213143 · Received October 29, 2008

    Report

    Report Number
    1423500-2007-88861
    Event Type
    Malfunction
    Date Received
    October 29, 2008
    Date of Event
    June 22, 2007
    Report Date
    July 5, 2007
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 AUGUST

    Description of Event or Problem · 1

    A HOME PATIENT¿S DAUGHTER REPORTED A HOMECHOICE CASSETTE THAT HAD A HOLE IN IT WHICH CAUSED FLUID TO LEAK OUT DURING PRIMING. THE HOLE WAS CAUSED BY THE PLASTIC SHEETING NOT BEING FIRMLY ATTACHED TO THE CASSETTE. THE CUSTOMER COULD NOT RECALL THE LOT NUMBER OF THE PRODUCT AND HAD DISCARDED THE SAMPLE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE INTEGRATED APD SETWITH CASSETTE 3-PRONG 78FKX FKX BAXTER HEALTHCARE CORPORATION UNK

    Patients

    Seq Age Sex Outcome Treatment
    1