BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2230531 · Received September 1, 2011

    Report

    Report Number
    1423500-2011-11525
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 24, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED AT BAXTER FOR EVALUATION. HOWEVER, THE EVALUATION IS NOT COMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE (HC) DEVICE WAS RETURNED AND WAS EVALUATED BY THE PRODUCT ANALYSIS LAB (PAL) FOR THE REPORTED ISSUE OF SYSTEM ERROR (SE) 1103 (HEATER PLATE FAILED). THE RETURN INSTRUMENT TEST/EVALUATION (RITE) FUNCTIONAL TEST FAILED SPECIFICATIONS FOR HEATER BAG TEMPERATURE FAILED. THE REPORTED ISSUE WAS CONFIRMED BY REVIEW OF THE LOGS BUT NOT DUPLICATED DURING PAL EVALUATION. POWER WAS CYCLED TO DEVICE AND A SHORT THERAPY WAS RUN WHILE BEING MONITORED IN CYCLER REMOTE TOOLBOX 8.800 TEMPMON. HEATER DID NOT APPEAR TO BE FUNCTIONING, DEVICE WAS ONLY SHOWING AMBIENT BAG TEMPERATURES AND NOT ATTEMPTING TO HEAT FLUID. RESISTANCE ACROSS HEATER PAN COILS WAS MEASURED AND FOUND TO NOT BE WITHIN SPECIFICATIONS. RESISTANCE MEASURES OPEN, INDICATING A FAILURE OF THE HEATER PAN. THE ASSIGNABLE CAUSE OF THE REPORTED ISSUE AND THE RITE FUNCTIONAL TEST FAILURES IS DETERMINED TO BE A FAILED HEATER PAN. REVIEW OF THE DEVICE LOGS FOUND AN ADDITIONAL ISSUE SE 2330 WHICH WAS DETERMINED TO BE A SYMPTOM OF THE REPORTED ISSUE, THEREFORE RELATED. THE ASSIGNABLE CAUSE FOR THE SE 2330 WAS UNDETERMINED. THERE WAS NOT ENOUGH OBJECTIVE EVIDENCE FOUND DURING EVALUATION TO MAKE A DETERMINATION. THE HEATER PAN WILL BE SCRAPPED DURING SERVICING.

    Description of Event or Problem · 1

    A SYSTEM ERROR (SE) 2330 ALARM WAS IDENTIFIED IN THE LOG OF A RETURNED HOMECHOICE DEVICE. IT IS UNKNOWN IF THIS ALARM OCCURRED DURING PATIENT THERAPY; HOWEVER, NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR