BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1891919 · Received November 5, 2010

    Report

    Report Number
    1423500-2010-05383
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    September 27, 2010
    Report Date
    October 14, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    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 BY BAXTER, HOWEVER THE EVALUATION HAS NOT BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING EVALUATION OF A RETURNED HOMECHOICE (HC) MACHINE, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED ON (B)(6) 2010 DURING DRAIN CYCLE 1. THE PATIENT'S DRAIN VOLUME WAS 145ML.THE FILL VOLUME WAS 100ML. THIS MEETS IIPV CRITERIA. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE EVALUATION DID NOT CONFIRM ANY FAILURE OR MALFUNCTION OF THE DEVICE THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THIS IIPV DISCOVERED DURING EVALUATION. BASED ON A REVIEW OF ALL AVAILABLE THERAPY LOG DATA, THE MOST PROBABLE CAUSE OF THE IIPV WAS DETERMINED TO BE INSUFFICIENT DRAIN, FALSE EMPTY DETECT AT INITIAL DRAIN. THE DEVICE WILL BE ROUTED TO THE SERVICE AREA. PRODUCT SURVEILLANCE CONTACTED THE NURSE ON (B)(6) 2010. ACCORDING TO THE NURSE SHE WAS NOT AWARE OF THIS DRAIN VOLUME; HOWEVER, THE PATIENT'S FILL VOLUME WAS 100ML BECAUSE SHE WAS A NEW PATIENT. THE PATIENT HAS RESUMED THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THE HC WAS EVALUATED BY THE PRODUCT ANALYSIS LAB (PAL). THE DEVICE PASSED THE HOMECHOICE RETURN INSTRUMENT TEST / EVALUATION (RITE) ELECTRICAL TEST BUT FAILED THE RITE FUNCTIONAL TEST DUE TO A RLS 153 ALARM. CONTINUED REVIEW OF THE DEVICE LOGS REVEALED AN OCCURRENCE OF INCREASED INTRA-PERITONEAL VOLUME (IIPV) HAD OCCURRED ON (B)(6) 2010 DURING CYCLE 1 WHEN THE DEVICE USER DRAINED 145 ML, WHICH WAS GREATER THAN 130% OF THE FILL VOLUME OF 100 ML AND MET PEDIATRIC IIPV CRITERIA. THE PAL EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE IIPV FOUND IN THE DEVICE LOGS. THE ASSIGNABLE CAUSE OF THE PEDIATRIC IIPV FOUND IN THE LOGS WAS DETERMINED TO BE: INSUFFICIENT DRAIN, FALSE EMPTY DETECT AT INITIAL DRAIN. THE DEVICE WAS SUBSEQUENTLY FORWARDED TO SERVICE. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED ON (B)(6) 2010 DURING DRAIN CYCLE 1. THE PATIENT'S DRAIN VOLUME WAS 145 ML. THE FILL VOLUME WAS 100 ML. THIS MEETS IIPV CRITERIA. PRODUCT SURVEILLANCE CONTACTED THE NURSE ON (B)(6) 2010. ACCORDING TO THE NURSE SHE WAS NOT AWARE OF THIS DRAIN VOLUME, HOWEVER, THE PATIENT'S FILL VOLUME WAS 100 ML BECAUSE SHE WAS A NEW PATIENT. THE PATIENT HAS RESUMED THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO FURTHER INFORMATION WAS AVAILABLE.

    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 54 YR