BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2140270 · Received June 26, 2011

    Report

    Report Number
    1423500-2011-08374
    Event Type
    Malfunction
    Date Received
    June 26, 2011
    Date of Event
    June 18, 2011
    Report Date
    June 18, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    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 EVENT LOG CONFIRMED THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT, BUT NOT DUPLICATED DURING THE PAL EVALUATION. THE PAL EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE CAUSE OF THE IIPV WAS DETERMINED TO BE INSUFFICIENT DRAIN DUE TO ONE OR MORE CYCLES ADVANCING TO THE NEXT FILL WHEN SLOW / NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. A SERVICE HISTORY REVIEW (SHR) REVEALED THAT NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE IIPV. 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, THE HOME PATIENT (HP) STATED FELT TOO FULL SO HE PUT HIMSELF INTO A MANUAL DRAIN AND DRAINED 3589ML BEFORE GOING TO STOPPED DWELL. THE FILL VOLUME IS 2000ML. THE HP STATED JUST WANTED TO END THERAPY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) WOULD SWAP AND ADVISED TO MAKE THE REGISTERED NURSE (RN) AWARE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. ON (B)(4) 2011, PRODUCT SURVEILLANCE CONTACTED THE HP'S PERITONEAL DIALYSIS NURSE (PDN) REGARDING THE REPORTED INCREASED INTRA-PERITONEAL VOLUME (IIPV). THE PDN STATED THE HP IS SENSITIVE TO THE AMOUNT OF SOLUTION IN HIM. THE PDN WAS NOT AWARE IF THE HP RECEIVED THE NEW HC YET BUT THE HP HAS NOT REPORTED ANY OTHER 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 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR