BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2083531 · Received May 10, 2011

    Report

    Report Number
    1423500-2011-05710
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 23, 2011
    Report Date
    April 23, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE (HC) DEVICE WAS RECEIVED FOR EVALUATION AT THE PRODUCT ANALYSIS LAB (PAL). A REVIEW OF THE DEVICE LOGS CONFIRMED THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT, BUT DID NOT DUPLICATE DURING THE PAL EVALUATION. A CAUSE WAS UNDETERMINED. A DEVICE HISTORY REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE IIPV EVENT DURING THE MANUFACTURE OF THE LOT OR SERIAL NUMBER. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. ADDITIONAL INVESTIGATION IS BEING CONDUCTED THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT YET BEEN RECEIVED BUT AN EVALUATION IS EXPECTED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REQUEST ASSISTANCE ON THE HOME CHOICE (HC). PER THE INITIAL REPORT, DURING TROUBLESHOOTING FOR A CHECK PATIENT LINE ALARM, THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP DOWN ARROW TO THE INITIAL DRAIN, DRAIN VOLUME 5240ML. THE HP STATED HE DRAINED 3L EARLIER WITH A MANUAL BAG AND PUT BACK IN 2500ML. THE HP STATED HE NEVER FELT OVERFILLED. THE HP WAS CERTAIN THE HC WAS WRONG AND WANTED A NEW HC. THE TSR EXPLAINED THE SWAP AS A PRECAUTIONARY MEASURE. THE TSR ASSISTED WITH ENDING THERAPY. THE HP WOULD DO A MANUAL BAG AND WOULD SPEAK TO THE RN IN THE MORNING ABOUT THE ISSUE. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. ON (B)(6) 2011, PRODUCT SURVEILLANCE RECEIVED A RETURNED CALL FROM THE HP'S PERITONEAL DIALYSIS NURSE (PDN). THE PDN VERIFIED THE HP'S LARGEST PRESCRIBED FILL VOLUME (LPFV) IS 3000ML ON THE CYCLER AND A LAST FILL OF 2500ML. THE PDN STATED SHE WAS NOT AWARE OF THE EVENT AND WOULD FOLLOW UP WITH THE PATIENT. THE PDN STATED THE HP HAS NOT REPORTED ANY SYMPTOMS OR OTHER DRAIN VOLUMES THAT MEET INCREASED INTRAPERITONEAL VOLUME (IIPV) CRITERIA. THE PDN CONFIRMED THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT AND THAT THE HP WAS DOING WELL WITH THE FOLLOWING TREATMENTS. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS.

    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