BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1051226 · Received May 23, 2008

    Report

    Report Number
    1423500-2008-00403
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    April 6, 2008
    Report Date
    April 10, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF BATCH REVIEW.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED A BAXTER HOME PT SERVICE REP AND REPORTED A HOMECHOICE CASSETTE WITH HOLES IN THE LINE. PRODUCT SURVEILLANCE CONTACTED HP. HP STATED SHE NOTICED FLUID ON CARPET IN THE MIDDLE OF THE NIGHT AFTER WAKING UP AND TRYING TO RESOLVE UNK ALARM. HP PULLED ON LINES IN ATTEMPT TO RESOLVE ALARM BUT STATED THAT WAS NOT THE CAUSE OF FLUID LEAK. HP STATED THERE WERE 2 HOLES IN LINES, POSSIBLY ON THE 2ND AND 3RD SUPPLY LINE. HP STATED LEAK OCCURRED DURING PT USE BUT COULD NOT REMEMBER THE EXACT PROCESS STEP. HP HAD TO RESTART THERAPY WITH NEW SUPPLIES. CASSETTE WAS NOT BEING REUSED. HP DOES NOT HAVE PETS. HP NOTICED NO DAMAGE TO OVERPOUCH OR CARTON IN WHICH THE HOMECHOICE CASSETTE WAS DELIVERED. HP DID NOT USE SHARP OBJECTS TO OPEN CARTON OR OVERPOUCH IN WHICH HOMECHOICE CASSETTE WAS DELIVERED. THE HP DISCARDED SAMPLE. HP INFORMED HER PD NURSE OF LEAKING HOMECHOICE CASSETTE AND STATED THERE WAS NO PT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG 78FKX FKX BAXTER HEALTHCARE H08A20016

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR