BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3032451 · Received April 3, 2013

    Report

    Report Number
    1416980-2013-08207
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 17, 2013
    Report Date
    March 17, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER THE SAMPLE WAS NOT AVAILABLE AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING THERAPY ASSISTANCE, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE. THE HOME PATIENT (HP) WAS NOT CONNECTED TO THE MACHINE AND STATED SHE NOTICED THE PATIENT LINE WAS LEAKING. THEY ADVISED THEM TO CONTACT THE REGISTERED NURSE (RN) TO HAVE THE PROGRAMMING REVIEW CORRECTED. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT IN REGARDS TO A LEAK AND SHE SAID THAT WHEN SHE REMOVED THE CASSETTE FROM THE MACHINE THAT DAY SHE NOTICED A SMALL HOLE IN THE PATIENT LINE WHERE THE SOLUTION WAS LEAKING FROM. SHE DID NOT NOTICE ANYTHING ELSE WRONG WITH HER SUPPLIES. SHE SAID SHE WAS CURRENTLY AWAITING HER NURSE TO COME HELP HER REPROGRAM HER MACHINE SINCE SHE PRESSED ALL THOSE BUTTONS THAT DAY WHEN SHE HAD THE LEAK. SINCE THEN SHE HAS BEEN COMPLETING THERAPY SUCCESSFULLY USING MANUAL SUPPLIES. THERE WAS PATIENT INVOLVEMENT BUT NO REPORTED INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136817 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR HOME CHOICE