BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3160008 · Received June 10, 2013

    Report

    Report Number
    1416980-2013-14868
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 17, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER. THE INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION BUT THE EVALUATION HAS NOT YET BEEN COMPLETED. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING THE REVIEW OF THE DEVICE LOG IT WAS FOUND THAT THE VOLUME OF FLUID DRAINED MET THE CURRENT CRITERIA FOR THE INCREASED INTRA-PERITONEAL VOLUME. DURING THE EXTERNAL AND INTERNAL INSPECTION OF THE DEVICE NO ISSUES WERE NOTED. ALSO, THE DEVICE HAD PASSED THE HOMECHOICE RETURN INSTRUMENT TEST/EVALUATION (RITE) ELECTRICAL TEST AND RITE FUNCTIONAL TEST. DURING MULTIPLE SIMULATED THERAPIES NO ISSUES WERE FOUND. THE CAUSE OF THE REPORTED ISSUE WAS DETERMINED TO BE FALSE EMPTY DETECT AND USE ERROR, INAPPROPRIATE BYPASS OF THE LOW DRAIN VOLUME ALARM, NOT INCLUDING I-DRAIN. A REVIEW OF THE HOMECHOICE / HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE LABELING WAS PERFORMED. SECTION ON "TROUBLESHOOTING" GIVES INSTRUCTIONS ON HOW TO BYPASS LOW DRAIN VOLUME ALARM. THE WARNING STATES "BYPASSING A LOW DRAIN VOLUME ALARM CAN LEAVE FLUID IN THE PERITONEAL CAVITY AND RESULT IN AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION." A FORMAL REVIEW OF THE LABELING WILL BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOME PATIENT (HP) RECEIVED A HIGH DRAIN 103 ALARM ON THE HOMECHOICE (HC) MACHINE AFTER USE. A HIGH DRAIN ERROR ALARM IS INDICATIVE OF AN IIPV EVENT. THIS ALARM INDICATES THE PATIENT DRAINED GREATER THAN 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME IN STANDARD MODE. THE CAREGIVER (CG) STATED THAT THERE WERE MULTIPLE LOW DRAIN ALARMS DURING THE LAST THERAPY AND THEY HAD BYPASSED INITIAL DRAIN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND ARRANGED TO SWAP THE HC. THE TSR EXPLAINED TO USE OF CONTINUOUS AMBULATORY PERITONEAL DIALYSIS UNTIL THE NEW MACHINE ARRIVED. THE TSR ALSO ADVISED THE CG TO SPEAK WITH THE REGISTERED NURSE ABOUT MISSING TWO CYCLES OF THERAPY AS THE HP IS DIABETIC. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED IN ASSOCIATION WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260136 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE