BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2962613 · Received February 14, 2013

    Report

    Report Number
    1416980-2013-03875
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 1, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A REPORT OF A LEAK WAS NOT CONFIRMED. THE ROOT CAUSE WAS UNDETERMINED. THE SAMPLE WAS UNAVAILABLE 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 SERVICE CENTER REGARDING A LEAK WHICH OCCURRED ON THE HOMECHOICE (HC) DURING DWELL 2. THE HOME PATIENT (HP) WOKE UP WHILE IN DWELL 2 AS THE HC WAS MAKING A SUCKING NOISE. UPON FURTHER INSPECTION, THE HP FOUND WETNESS ON THE FLOOR. AT THE TIME OF THE CALL THERE WERE NO ALARMS. THE HP COULD NOT FIND ANY LEAKS. THE PATIENT WAS CONNECTED AT THE TIME OF THE LEAK. THE PATIENT LINE HAD BEEN PROPERLY PRIMED AND NO PATIENT EXTENSIONS WERE IN USE. THE PATIENT LINE HAD NOT SEPARATED FROM THE TRANSFER SET. THE PATIENT DID NOT PRESS GO TO INITIATE THERAPY PRIOR TO CONNECTING. A DUMMY TUMMY WAS NOT IN USE. ALL OF THE BAGS WERE PROPERLY CONNECTED AND THERE WERE NO OPEN CLAMPS ON UNUSED LINES. THE SET WAS NOT BEING REUSED. THE PATIENT DID NOT HAVE PETS WHICH COULD CAUSE DAMAGE TO THE SUPPLIES. THERE WAS NO DAMAGE NOTED ON THE OVER POUCH OR CARTON IN WHICH THE CASSETTE WAS DELIVERED. A SHARP OBJECT WAS NOT USED TO OPEN THE CARTON OR OVERPOUCH. THE SUPPLIES HAD NOT BEEN DAMAGED BY AN OUTLET PORT CLAMP OR ASSIST DEVICE. THE HP WANTED TO END THERAPY AND FINISH THERAPY VIA A MANUAL EXCHANGE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) REFERRED THE HP TO HIS ON CALL REGISTERED NURSE FOR FURTHER MEDICAL INSTRUCTIONS AND ASSISTED THE HP END THERAPY. PROPER PROCEDURES WERE REVIEWED. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. BAXTER PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT. HE STATED THAT HE FOUND THAT THERE WAS A VERY SMALL HOLE IN THE PATIENT LINE THAT WAS LEAKING. HE STATED THAT HE APPLIED PRESSURE TO ONE OF HIS SOLUTION BAGS IN ORDER TO SEE IF THE BAG WAS THE ISSUE, AND THAT IS WHEN THE PATIENT LINE BEGAN TO LEAK AND HE DISCOVERED THE HOLE. HE CONTACTED HIS NURSE AND WAS GIVEN PREVENTATIVE ANTIBIOTICS. THERAPY SINCE HAS BEEN GOING WELL, AND THERE WERE NO ADVERSE EFFECTS REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64685 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR HOMECHOICE