BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2950596 · Received February 8, 2013

    Report

    Report Number
    1416980-2013-03321
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    December 30, 2012
    Report Date
    December 31, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ISSUE OF IIPV WAS CONFIRMED IN THE EVENT HISTORY LOG REVIEW. THE DEVICE WAS DETERMINED TO MEET FUNCTIONAL AND ELECTRICAL PERFORMANCE SPECIFICATION REQUIREMENTS PER RITE TESTING. NO DEVICE FAILURE OR MALFUNCTION WAS IDENTIFIED DURING EVALUATION THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY; THEREFORE THE DEVICE MET PRODUCT SPECIFICATION IN RELATION TO THE REPORTED ISSUE OF IIPV. THE CAUSE WAS DETERMINED TO BE FALSE EMPTY DETECT AND USE ERROR, INAPPROPRIATE BYPASS OF THE LOW DRAIN VOLUME ALARM, NOT INCLUDING I-DRAIN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TECHNICAL SERVICES (BTS) REGARDING ASSISTANCE WITH NOT DRAINING PROPERLY ON THE HOMECHOICE MACHINE (HC). THE HOME PATIENT (HP) STATED HE ALSO GETS REPEATED LOW DRAIN VOLUME ALARMS. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) CONFIRMED THAT THE HP CLEARS THESE ALARMS BY BYPASSING THEM. THE TSR EXPLAINED THAT AN IMPROPER BYPASS CAN MAKE THE HC PUT IN A FULL FILL INSTEAD OF A PARTIAL FILL. THE HP STATED THIS MORNING WHEN HE GOT DONE WITH THERAPY, HE FELT TOO FULL AND HAD TROUBLE BREATHING. THE HP STATED HE WEIGHED HIMSELF THEN DID A MANUAL DRAIN AND WEIGHED AGAIN. THE WEIGHT DIFFERENCE WAS 7LBS, APPROXIMATELY 3000ML, PLUS THE LAST FILL VOLUME OF 2000ML. THE HP STATED HE ALREADY SPOKE WITH HIS NURSE ABOUT THE EVENT. PRODUCT SURVEILLANCE MADE CONTACT WITH THE PERITONEAL DIALYSIS (PD) NURSE REGARDING THE REPORTED INCIDENT. THE NURSE REPORTED SHE MADE CONTACT WITH THE PATIENT. THE PATIENT WAS HOSPITALIZED FOR HAVING SHORTNESS OF BREATH AND DISCHARGED HOME. THE PATIENT WAS READMITTED TO THE HOSPITAL AGAIN FOR SHORTNESS OF BREATH AND REMAINED IN THE HOSPITAL. THE PATIENT WAS DIAGNOSED WITH PNEUMONIA. PER THE NURSE THE PATIENT HAS RECEIVED LASIX (DOSE, ROUTE, FREQUENCY) WHILE IN THE HOSPITAL, PD THERAPY IS ONGOING AT THIS TIME, AND A HIGHER CONCENTRATION (4.25%) HAS BEEN USED TO DRAIN EXCESS FLUID. WHEN THE PATIENT IS DISCHARGED HOME, THE PD NURSE PLANS TO RETRAIN THE PATIENT ON CHOOSING THE CORRECT STRENGTH OF SOLUTION TO USE FOR PD THERAPY AND TO MONITOR HIS INTAKE OF ORAL FLUIDS. PER THE PD NURSE, THE PATIENT IS CURRENTLY USING LOW CALCIUM DIANEAL SOLUTION BAGS. PER THE PD NURSE, THE EVENT OF PNEUMONIA, FEELING FULLNESS AND HAVING TROUBLE BREATHING WERE UNRELATED TO A BAXTER DEVICE, DISPOSABLES, OR SOLUTIONS. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED. DURING DEVICE EVENT LOG REVIEW ON (B)(4) 2013, A BAXTER SERVICE TECHNICIAN DISCOVERED AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT, SHOWING A DRAIN VOLUME OF 3352 ML DURING CYCLE 4. THE PATIENT'S MAXIMUM PRESCRIBED FILL VOLUME WAS 2000ML. BAXTER QUALITY ENGINEERING HAS CONFIRMED THE HP REPORTED EVENT AS AN IIPV EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53929 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE