BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2073017 · Received April 29, 2011

    Report

    Report Number
    1423500-2011-05208
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT'S REPORTED DRAIN VOLUME OF 2538 ML, WHICH IS A VOLUME OF FLUID THAT MEETS INCREASED INTRAPERITONEAL VOLUME (IIPV) CRITERIA. AND REPORTED ISSUE OF "PULLING & HIGH DRAIN VOLUME" WAS UNABLE TO BE CONFIRMED DUE TO THE EVENT & THERAPY LOG WAS OVERWRITTEN. A CAUSE WAS UNDETERMINED. 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 IS NOT AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    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) WANTED TO BYPASS TO DRAIN 4 OF 4, DRAIN VOLUME 2538ML. THE HP STATED HE WANTED TO BYPASS THE DRAIN BECAUSE IT WAS PULLING. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) REVIEWED THE HP'S THERAPY: TIDAL, TOTAL VOLUME 7000ML, THERAPY TIME 8:30, FILL VOLUME 1500ML, TIDAL PERCENTAGE 95%, TOTAL ULTRAFILTRATION 0ML, LAST FILL VOLUME 1300ML. THE TSR ASSISTED THE HP WITH BYPASSING TO DRAIN 4 OF 4. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THIS EVENT MEETS IIPV CRITERIA. ON (B)(6) 2011, PRODUCT SURVEILLANCE CONTACTED THE HP'S PERITONEAL DIALYSIS NURSE (PDN) REGARDING THE REPORT OF PULLING AND HIGH DRAIN VOLUME. THE PDN VERIFIED THE HP'S LARGEST PRESCRIBED FILL VOLUME (LPFV) IS 1500ML. THE PDN DID NOT REQUEST SWAP OF THE HP'S DEVICE. THE PDN STATED 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 PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR