BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2983162 · Received February 28, 2013

    Report

    Report Number
    1416980-2013-04931
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 12, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT WAS CONFIRMED. THE CAUSE OF THE USE ERROR WAS UNDETERMINED. THIS REPORT OF USE ERROR WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION THEREFORE NO FURTHER INVESTIGATION WILL BE PERFORMED. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A SAMPLE EVALUATION WILL NOT BE CONDUCTED. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE NO BATCH REVIEW COULD BE PERFORMED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE, DURING DWELL 2 OF 4. THE TSR HAD THE HP CHECK THE LINES AND BAGS AND THE HP HAD A CLAMP OPEN ON AN UNUSED SUPPLY LINE. THE HP UNDERSTOOD AND THE HP ENDED THERAPY AND WOULD CALL THE RN. THE PATIENT WAS CONNECTED EITHER AT THE TIME OF THE ALARM OR OBSERVED AIR. THE PATIENT LINE WAS PROPERLY PRIMED BEFORE CONNECTING. PATIENT EXTENSION LINES WERE NOT USED. THE PATIENT DID NOT DISCONNECT PRIOR TO THE ALARM OR OBSERVED AIR. ALL BAGS WERE PROPERLY CONNECTED. THERE WAS NOT ANYTHING UNUSUAL NOTED ABOUT THE SUPPLIES. THE SUPPLIES WERE NOT DAMAGED BY AN OUTLET PORT CLAMP OR AN ASSIST DEVICE USED TO MAKE THE CONNECTIONS. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE REPORTER. IT WAS UNKNOWN HOW THE HOME PATIENT (HP) WOULD COMPLETE 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
    87514 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR HOME CHOICE