BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1801701 · Received August 16, 2010

    Report

    Report Number
    1423500-2010-02533
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    May 4, 2010
    Report Date
    May 4, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS REQUESTED THROUGH THE PERITONEAL DIALYSIS NURSE WHO WOULD ASK THE PATIENT IF SHE WOULD BE WILLING TO RETURN IT FOR EVALUATION. THUS FAR, THE DEVICE HAS NOT BEEN RETURNED. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE REPORTED ON THE INITIAL MDR WAS INCORRECT AND SHOULD HAVE BEEN DOCUMENTED AS (B)(6), 2010. DEVICE EVALUATION: THE REPORTED DIFFICULTY OF THE PATIENT STOPS BREATHING/CRAMPS WAS NEITHER CONFIRMED IN THE DEVICE LOGS NOR DUPLICATED DURING EVALUATION. THE DEVICE WAS RECEIVED IN POOR CONDITION WITH PAINT PEELING ON THE HEATER PAN NEAR THE BUTTON. THE REPORTED DIFFICULTY OF AN INCOMPLETE DRAIN WAS NEITHER CONFIRMED IN THE DEVICE LOGS NOR DUPLICATED DURING EVALUATION. THE DEVICE WAS DETERMINED TO MEET FUNCTIONAL AND ELECTRICAL PERFORMANCE SPECIFICATION REQUIREMENTS AND PASSED THE HOMECHOICE RETURN INSTRUMENT TEST. REVIEW OF THE RETURNED DEVICE LOGS REVEALED NO PATIENT DRAIN VOLUMES THAT MET OR EXCEEDED THE INCREASED INTRAPERITONEAL VOLUME (IIPV) CRITERIA. THE ASSIGNABLE CAUSE OF THE REPORTED DIFFICULTIES WAS UNDETERMINED. THE ASSIGNABLE CAUSE OF THE ADDITIONAL DIFFICULTY OF PAINT ON THE HEATER PAN BUBBLING NEAR THE BUTTON WAS DETERMINED TO BE PHYSICAL DAMAGE. THE DEVICE WAS SUBSEQUENTLY FORWARDED TO SERVICE. A LABELING REVIEW WAS PERFORMED AND THE LABELING WAS FOUND TO BE SUFFICIENT.

    Description of Event or Problem · 1

    DURING A FOLLOW UP CALL ON THE "URGENT PRODUCT RECALL LETTER DATED (B)(6) 2010" THE FOLLOWING INFORMATION WAS OBTAINED: THE PATIENT STATED SHE STOPS BREATHING, HAS CRAMPS AND REPORTS THAT HER HOMECHOICE MACHINE DOES NOT DRAIN ENOUGH FLUID AND THEN STARTS FILLING AGAIN. THE PATIENT STATED THAT SHE OVERFILLS FREQUENTLY. SHE HAS A FILL VOLUME OF 1500 MILLILITERS (ML) AND DRAINS 400ML TO 500ML ABOVE THE 1500ML WHEN SHE WAKES UP. THERE ARE NO VOLUMES REPORTED THAT FULFILL CRITERIA CONSISTENT WITH INCREASED INTRA-PERITONEAL VOLUME OR AN OVERFILL EVENT. THE NURSE STATED THE PATIENT HAS SLEEP APNEA, BUT SHE COULD NOT MEDICALLY CONFIRM THE EVENTS OF CRAMPING OR THE PATIENT STOPPING BREATHING BECAUSE THE PATIENT DID NOT REPORT THE EVENTS TO THE CLINIC. THE NURSE STATED THE PATIENT WAS NON-COMPLIANT AND HAD NOT BEEN TO THE CLINIC IN MONTHS.

    Description of Event or Problem · 1

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other