BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2970180 · Received February 20, 2013

    Report

    Report Number
    1416980-2013-04263
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ISSUE WAS CONFIRMED IN THE EVENT HISTORY LOG REVIEW. THE DEVICE WAS DETERMINED TO MEET FUNCTIONAL AND ELECTRICAL PERFORMANCE SPECIFICATION REQUIREMENTS PER RITE TESTING. THE DEVICE PASSED BOTH THE HOMECHOICE RETURN INSTRUMENT TEST / EVALUATION (RITE) ELECTRICAL TEST AND THE RITE FUNCTIONAL TEST SPECIFICATIONS. THE DEVICE WAS DETERMINED TO MEET SPECIFICATIONS FOR THE REPORTED DIFFICULTY OF A HIGH DRAIN 105/CALL PD NURSE ALARM. THE NURSE WAS ADVISED OF THE CAUSE OF THE IIPV EVENT. THE CAUSE WAS DETERMINED TO BE USE ERROR, TIDAL TOTAL ULTRAFILTRATION REMOVAL SET TOO LOW. THE HOMECHOICE APD SYSTEMS TRAINER'S GUIDE GIVES INSTRUCTIONS ON HOW TO SET THE TIDAL THERAPY SETTINGS. PG 12-30 HAS THE WARNING THAT "A TOTAL UF VOLUME SET TOO LOW CAN RESULT IN A GRADUAL BUILD-UP OF UF VOLUME DURING THE THERAPY. THIS CAN RESULT IN AN IIPV SITUATION. " SECTION 13 "TOPIC 4: TIDAL THERAPY" GIVES THE TRAINER INSTRUCTIONS ON HOW TO PROPERLY SET TIDAL THERAPY VALUES. ON PG 13-9 THE INSTRUCTIONS STATE "A GOOD STARTING POINT WOULD BE, AT A MINIMUM, TO REVIEW A DRAIN HISTORY OVER THE PREVIOUS SEVEN TREATMENT DAYS. THE TOTAL AMOUNT OF UF OVER THE SEVEN DAYS SHOULD BE ADDED AND THEN DIVIDED BY SEVEN TO OBTAIN AN AVERAGE DAILY UF GOAL." THE SUGGESTED SETTING FOR TOTAL UF IS DESCRIBED ON PG 12-30 AS "SEVENTY PERCENT OF THE NORMAL NIGHT UF IS A GOOD STARTING POINT FOR DETERMINING THE OPTIMUM TOTAL UF." A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TECHNICAL SERVICES (BTS) REGARDING ASSISTANCE WITH A HIGH DRAIN 105 ALARM (INDICATES THE PATIENT DRAINED GREATER THAN 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME, MEETING INCREASED INTRA-PERITONEAL VOLUME (IIPV) CRITERIA) AT THE END OF THERAPY ON THE HOMECHOICE MACHINE(HC). THE TECHNICAL SERVICE REPRESENTATIVE(TSR) ASSISTED THE HOME PATIENT (HP) TO REVIEW THE THERAPY LOG TO FIND CYCLE 5 UF WAS 2423ML. THE TSR EXPLAINED THE ALARM. THE HP STATED SHE WAS USING DIFFERENT CONCENTRATIONS THE LAST TWO NIGHTS BECAUSE THE PERITONEAL DIALYSIS NURSE WANTED HER TO DRAIN MORE. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73681 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE