BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2992451 · Received March 7, 2013

    Report

    Report Number
    1416980-2013-05479
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    March 2, 2013
    Report Date
    March 2, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT WAS CONFIRMED. THE CAUSE OF THE USE ERROR WAS UNDETERMINED. THE LABELING INSTRUCTS THE PATIENT NOT TO REUSE SUPPLIES, AND THE SUPPLIES ARE LABELED FOR SINGLE-USE. THIS REPORT OF USE ERROR WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION THEREFORE NO FURTHER INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING EMPTY BAGS WHICH OCCURRED ON THE HOMECHOICE (HC) DURING FILL, AND DURING TROUBLESHOOTING IT WAS DISCOVERED THAT THE HOME PATIENT (HP) HAD REUSED HER SUPPLIES. WHEN THE HP CALLED, SHE ONLY HAD SOLUTION IN THE FINAL BAG. THE BAXTER TECHNICAL SERVICES REPRESENTATIVE (TSR) BYPASSED THE HC TO DWELL 3 OF 5. THE HP THEN STATED THAT SHE HAD STARTED THERAPY THAT NIGHT WITH A USED SET UP. THE TSR REVIEWED THE ALARM LOG AND FOUND A CHECK LINES AND BAGS ALARM. THE TSR THEN ENDED THERAPY. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97140 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR HOMECHOICE