BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3073461 · Received April 23, 2013

    Report

    Report Number
    1416980-2013-10161
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 12, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW WILL NOT BE CONDUCTED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4).THE SYSTEM ERROR 2240 ALARM IS CONFIRMED AS THE HOME PATIENT STATED THE SUPPLY BAG FELL AND DISCONNECTED, WHICH ALLOWS AIR INTO THE SYSTEM AND CAUSE THE ALARM.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING A SYSTEM ERROR (SE) 2240 (AIR IN LINE) DURING DWELL 1 ON THE HOME CHOICE (HC). THE CAREGIVER (CG) STATED THE SUPPLY BAG FELL AND DISCONNECTED CAUSING THE SE 2240. THE CG STATED SHE HAD CALLED THE REGISTERED NURSE (RN), AND THE HOME PATIENT (HP) WOULD BE SEEN AT THE CLINIC IN THE MORNING. THERE WAS NO FURTHER THERAPY THAT NIGHT AND THE CG HAD ALREADY CLEARED THE ALARMS. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED TO GET THE DOOR OPEN SO THE CG MAY UNLOAD THE SET AND BAGS. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS 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
    175217 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR HOMECHOICE