BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3061585 · Received April 16, 2013

    Report

    Report Number
    1416980-2013-09407
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB. THE DEVICE PASSED BOTH THE HOMECHOICE RETURN INSTRUMENT TEST / EVALUATION (RITE) ELECTRICAL TEST AND THE RITE FUNCTIONAL TEST SPECIFICATIONS. THE CAUSE OF THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) IDENTIFIED IN THE DEVICE LOG WAS INSUFFICIENT DRAIN, USE ERROR AND TIDAL TOTAL UF REMOVAL SET TOO LOW. A REVIEW OF THE FOLLOWING LABELING WAS PERFORMED: HOMECHOICE / HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE, (B)(4). 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 BUILDUP 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. "

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE EVALUATION HAS NOT YET BEEN COMPLETED. 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

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT HIGH DRAIN 104 ALARM ON THE HOMECHOICE (HC) MACHINE AFTER USE AT THE END OF THERAPY. THE HOME PATIENT (HP) WANTED TO SWAP THE HC-PRO. THE HP STATED THAT THEY HAD PROBLEMS WITH THE DEVICE SINCE THEY HAVE RECEIVED IT. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) SWAPPED THE DEVICE. THE HP DOES NOT USE THE PROCARD AND THE REGISTERED NURSE (RN) WOULD PROGRAM THE NEW DEVICE. THE HP STATED THAT HE WOULD USE THE SAME DEVICE FOR THE NIGHT. THE ONLY NUMBERS THAT THE HP COULD OBTAIN FROM THE THERAPY WAS DRAIN VOLUME (DV) WHICH EQUALED 1849ML, LAST ULTRAFILTRATION EQUALED 3039ML AND THE LAST FILL VOLUME WAS UNKNOWN. THE AVERAGE DWELL TIME WAS 1 HOUR AND 49 MINUTES AND THERE WERE NO OTHER ISSUES. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162804 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR