BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2233933 · Received September 6, 2011

    Report

    Report Number
    1423500-2011-11702
    Event Type
    Malfunction
    Date Received
    September 6, 2011
    Date of Event
    August 19, 2011
    Report Date
    August 19, 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 DEVICE IS NOT AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ISSUE OF INCREASED INTRA-PERITONEAL VOLUME (IIPV) WAS CONFIRMED BASED ON A DRAIN VOLUME OF 4275ML AND A LARGEST PRESCRIBED FILL VOLUME OF 2500ML, WHICH MEETS IIPV CRITERIA. THE CAUSE WAS DETERMINED TO BE USE ERROR; INITIAL DRAIN ALARM SETTING WAS INAPPROPRIATELY PROGRAMMED. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THAT A LOOSE HARDWARE/ DEBRIS WAS FOUND DURING ROTATIONAL TEST; HOWEVER, THE REPORTED PROBLEM WAS NOT CONFIRMED VIA THE DEVICE HISTORY RECORD REVIEW. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE IS BEING INVESTIGATED THROUGH A CAPA.

    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) WAS FEELING OVERFULL AND WAS HAVING PROBLEMS BREATHING. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP START A MANUAL DRAIN, DRAIN VOLUME 4275ML. THE LAST FILL VOLUME WAS 500ML. THE HP WAS UNABLE TO DRAIN WHEN SHE DID HER MANUAL DRAIN, BUT DID THE MANUAL FILL OF 2000ML ANYWAY. THE HP THEN GOT ON THE HC AND DID THE INITIAL DRAIN AND FILL 1. THE TSR REVIEWED THE PROGRAMMING: INITIAL DRAIN ALARM (IDA) SETTING 80ML, FILL VOLUME 2500ML. THE TSR EXPLAINED THAT THE HP NEEDED TO CONTACT THE RN TO DECIDE HOW TO CONTINUE WITH THERAPY AND ALSO TO REVIEW THE PROGRAMMING FOR THE IDA. THE TSR ALSO TOLD THE HP THAT IF SHE WAS UNABLE TO DRAIN DO NOT CONTINUE WITH ANY KIND OF FILL WHETHER ON THE HC OR MANUAL AND TO CALL THE RN. THE HP FELT MUCH BETTER AND WAS EMPTY AND WOULD CALL THE RN TO DETERMINE HOW TO CONTINUE. 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 CONTACTED THE HP'S PERITONEAL DIALYSIS NURSE (PDN) REGARDING THE REPORTED INCREASED INTRA-PERITONEAL VOLUME (IIPV). THE PDN VERIFIED THE HP'S LARGEST PRESCRIBED FILL VOLUME (LPFV) IS 2500ML. 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 - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR