BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1874195 · Received October 19, 2010

    Report

    Report Number
    1423500-2010-04605
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 27, 2010
    Report Date
    September 27, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION EXPECTED BUT NOT YET COMPLETED. ANY RESULTS OF EVALUATION WILL BE PROVIDED IN A FOLLOW UP EMDR.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED FEELING BLOATED, AS IF HE HAD AN INCREASED INTRAPERITONEAL VOLUME (IIPV), DURING THERAPY USING THE HOMECHOICE CYCLER. THE CUSTOMER INITIATED A MANUAL DRAIN AND REMOVED 4770 ML, WHICH IS A VOLUME OF FLUID GREATER THAN THE LARGEST PRESCRIBED FILL VOLUME OF 2500 ML AND MET IIPV CRITERIA. THE REPORTED DIFFICULTY OF AN IIPV WAS CONFIRMED IN THE DEVICE LOGS BUT WAS NOT DUPLICATED DURING EVALUATION. REVIEW OF THE LOGS REVEALED THE CUSTOMER DISCONTINUED THERAPY EARLY ON (B)(6) 2010 AT 06:25 PRIOR TO DRAIN, LEAVING THE PATIENT WITH A RESIDUAL VOLUME OF 2141 ML. THE PATIENT INITIATED THE NEXT THERAPY AT (B)(6) 2010 @ 21:59. WHEN PROMPTED TO VERIFY THE INITIAL DRAIN ALARM SETPOINT, THE CUSTOMER ACCEPTED THE INITIAL DRAIN VOLUME OF 10 ML AND CONTINUED THERAPY. THE CUSTOMER DRAINED 18 ML DURING THE INITIAL DRAIN WHEN THE SYSTEM ADVANCED INTO FILL 1 AND DELIVERED THE PROGRAMMED FILL VOLUME (2500 ML). DURING CYCLE 1 THE PATIENT DRAINED OUT 4772 ML, WHICH CONFIRMED THE REPORTED DIFFICULTY. 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. THE PAL EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE IIPV. THE DEVICE FUNCTIONED NORMALLY DURING PAL TESTING. THE ASSIGNABLE CAUSE OF THE IIPV WAS DETERMINED TO BE: INSUFFICIENT DRAIN; FALSE EMPTY DETECT AND USE ERROR. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4). A SERVICE HISTORY REVIEW WAS PERFORMED AND REVEALED NO ISSUES RELATED TO THE REPORTED CONDITION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S (B)(4) TO REQUEST ASSISTANCE ON THE HOME CHOICE (HC) MACHINE. PER THE INITIAL REPORT, THE HOME PATIENT (HP) STATED HE LOOKED VERY BLOATED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP SIT UP AND START THE DRAIN. THE HP DRAINED OUT 4770 ML. THIS DRAIN MEETS OVERFILL CRITERIA. THE TSR WOULD SWAP THE HC. ON (B)(6) 2010 PRODUCT SURVEILLANCE CONTACTED THE HP PERITONEAL DIALYSIS NURSE (PDN) REGARDING THE REPORT OF LOOKING BLOATED. THE PDN STATED THE HP WAS IN THE CLINIC (B)(6) ((B)(6) 2010) AND WAS DOING FINE. THE PDN STATED THE HP BROUGHT THE PROCARD TO THE CLINIC AND THE PRESCRIPTION WAS CORRECT. THE PDN STATED THE HP HAD NOT RECEIVED THE REPLACEMENT HC YET BUT WAS OKAY USING MANUALS IN THE MEANTIME. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR