BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2843056 · Received November 21, 2012

    Report

    Report Number
    1416980-2012-05802
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 31, 2012
    Report Date
    October 31, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO BAXTER, THEREFORE NO EVALUATION CAN BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ISSUE OF IIPV WAS CONFIRMED OVER THE PHONE. THE DEVICE PASSED BOTH THE HC RETURN INSTRUMENT TEST / EVALUATION (RITE) ELECTRICAL TEST AND THE RITE FUNCTIONAL TEST. REVIEW OF SERVICE HISTORY REVEALED NO FAILURES/PROBLEMS THAT WERE THE SAME AS, OR SIMILAR TO, THE CURRENT DIFFICULTY AND THERE WAS NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. REVIEW OF THE DEVICE SERVICE HISTORY REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY OF IIPV-ADULT. THE ASSIGNABLE CAUSE WAS UNDETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TECHNICAL SERVICES(BTS) REGARDING ASSISTANCE WITH A HIGH DRAIN ALARM AT THE END OF THERAPY, WHICH WAS ON THE HOMECHOICE (HC). THE HOME PATIENT (HP) STATED SHE FELT FINE AND DID NOT FEEL AT ALL OVERFILLED DURING LAST NIGHT'S THERAPY. THE TECHNICAL SERVICE REPRESENTATIVE(TSR) ASSISTED THE HP TO REVIEW THE THERAPY. THE FILL VOLUME WAS SET TO 2000ML, LAST FILL VOLUME 2000ML, INITIAL DRAIN ALARM TO 1200ML. THE HP STATED THAT LAST NIGHT'S THERAPY THEY HAD AN INITIAL DRAIN VOLUME OF 1276ML, TOTAL FILL VOLUME OF 7998ML, AND TOTAL DRAIN VOLUME OF 10654ML. THE NURSE WAS CONTACTED ON (B)(6) 2012. THE NURSE STATED SHE WAS NOT AWARE OF THE EVENT, BUT WOULD FOLLOW UP WITH THE HP TO RESOLVE THE ISSUE. THE NURSE STATED THAT THE HP DID NOT DEVELOP ANY ADVERSE REACTIONS OR REQUIRE ANY MEDICAL INTERVENTION. THE NURSE STATED THE HP DID NOT REPORT ANY FURTHER ISSUES AND THEY WERE CURRENTLY PERFORMING THERAPY WITHOUT ANY COMPLICATIONS. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

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

    Patients

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