BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2842863 · Received November 21, 2012

    Report

    Report Number
    1416980-2012-05770
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    September 11, 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
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CONDITION OF IIPV WAS CONFIRMED BASED ON REPORTED DRAIN VOLUMES. 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 CAUSE WAS FALSE EMPTY DETECT AND USE ERROR, INAPPROPRIATE BYPASS OF THE LOW DRAIN VOLUME ALARM DURING INITIAL DRAIN.

    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 ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TECHNICAL SERVICES(BTS) REGARDING ASSISTANCE WITH A LOW DRAIN VOLUME ALARM DURING A PREVIOUS THERAPY ON THE HOMECHOICE MACHINE (HC). THE NURSE STATED SHE IS REVIEWING THE PRO CARD. THE NURSE STATED ON THE (B)(6) THE HOME PATIENT(HP) HAD AN INITIAL DRAIN OF 14ML WHICH SHOULD HAVE ALARMED AND SHE SEES THE LOW DRAIN VOLUME ALARM, BUT DOESN'T KNOW IF IT WAS FOR THAT. THE NURSE STATED IN DRAIN 1 THE HP DRAINED OUT 5790ML AND HIS FILL VOLUME WAS 2800ML. THE NURSE STATED SHE KNOWS THE DRAIN WAS CAUSED BY THE HP BYPASSING THE INITIAL DRAIN WHEN HE WASN'T EMPTY. THE NURSE WANTS TO KNOW IF THE HP HAS THE LATEST SOFTWARE. THE TECHNICAL SERVICE REPRESENTATIVE(TSR) ADVISED THE NURSE THAT ACCORDING TO THE SHIPPING DATE SHE DOES. THE NURSE STATED SHE DOESN?T UNDERSTAND WHY THE HC DOESN'T SHOW A HIGH DRAIN ALARM OCCURRING. THE TSR ADVISED THE NURSE THAT IF THE HP JUST CYCLED POWER THE HC WOULD NOT RECORD ANY FURTHER INFO ABOUT THERAPY FOR THAT NIGHT. THE HC UNIT WAS OPERATIONAL. 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 PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE