BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2851619 · Received November 29, 2012

    Report

    Report Number
    1416980-2012-06166
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 7, 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 HAS BEEN RECEIVED, AND THE EVALUATION IS IN PROCESS. THE REPORTED ISSUE OF IIPV-ADULT WAS CONFIRMED IN THE LOGS BUT NOT DUPLICATED DURING PAL EVALUATION. PROBABLE CAUSE WAS DETERMINED TO BE INSUFFICIENT DRAIN. FALSE EMPTY DETECT AT INITIAL DRAIN ALARM AND I-DRAIN ALARM VOLUME WAS MET. THE DEVICE WAS DETERMINED TO MEET FUNCTIONAL AND ELECTRICAL PERFORMANCE SPECIFICATION REQUIREMENTS PER RITE TESTING. DEVICE MEETS SPECIFICATION FOR THE REPORTED ISSUE OF IIPV-ADULT (HIGH DRAIN VOLUME 101). A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TECHNICAL SERVICES (BTS) REGARDING ASSISTANCE WITH A HIGH DRAIN ALARM AT THE START OF THERAPY ON THE HOMECHOICE MACHINE (HC). THE HOME PATIENT (HP) STATED THEY TURNED ON THE HC AND THE HIGH DRAIN ALARM CAME ON. THE HP STATED THEY FINISHED THE PREVIOUS THERAPY WITH NO ALARMS AND NO PROBLEMS. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO REVIEW THERAPY. THE INITIAL DRAIN VOLUME WAS 23ML, RECOVERED INITIAL DRAIN VOLUME WAS 0ML, LAST FILL VOLUME OF 14ML, TOTAL FILL VOLUME OF 9995ML, TOTAL DRAIN VOLUME OF 14082ML, AVERAGE DWELL OF 1:26, THERE WAS NO BYPASS, AND MANUAL DRAIN OF 0ML. THE HP STATED THEY DID NOT EXPERIENCE ANY INCREASE INTRA-PERITONEAL DIALYSIS SYMPTOMS. THE NURSE WAS CONTACTED ON (B)(6) 2012. THE NURSE STATED THAT THE HOME PATIENT (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.

    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 57 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE