BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2884180 · Received December 21, 2012

    Report

    Report Number
    1416980-2012-07996
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 29, 2012
    Report Date
    November 29, 2012
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PROBLEM WAS CONFIRMED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE PASSED HC RITE ELECTRICAL TEST, BUT FAILED A RITE FUNCTIONAL TEST DUE TO A HEATER BAG TEMP TEST, WHICH FAILED FOR PERFORMANCE SPECIFICATIONS. THE RITE FAILURE OF FAILED HEATER BAG TEMP TEST WAS NOT CONFIRMED IN THE EVENT HISTORY. DURING THE SAMPLE EVALUATION THE FAILURE DID NOT REOCCUR, THEREFORE, THE CONDITION WAS NOT CONFIRMED. THE ASSIGNABLE CAUSE FOR THE RITE FAILURE WAS NOT DETERMINED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE (HC) DEVICE, A BAXTER TECHNICIAN DETERMINED THE HC MACHINE FAILED THE FLUID TEMPERATURE DELIVERY VERIFICATION TEST. THE LAST FILL MEASUREMENT WAS IN A RANGE FROM 26.9 "C TO 26.6'C". THE RETURN INSTRUMENT TEST/EVALUATION (RITE) SPECIFICATION LIMITS ARE 35.0'C - 39.0'C. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1