BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE PRO

    MDR report key: 3816791 · Received May 19, 2014

    Report

    Report Number
    1416980-2014-15921
    Event Type
    Death
    Date Received
    May 19, 2014
    Report Date
    April 24, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT DATE - THE PT PASSED AWAY ON AN UNREPORTED DATE IN (B)(6) 2014. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE LOGS REVEALED NO SYSTEM ERRORS, ANOMALIES, HARDWARE DEVICE FAILURES OR INCREASED INTRAPERITONEAL VOLUME (IIPV) EVENTS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PRODUCT ANALYSIS LAB (PAL) EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WERE IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT PASSING AWAY. THE DEVICE PASSED THE HOMECHOICE RITE (RETURN INSTRUMENT TEST/EVALUATION) ELECTRICAL TEST; HOWEVER THE DEVICE FAILED THE HOMECHOICE RITE FUNCTIONAL TEST DUE TO A VOLUMETRIC STANDARD LEFT PRESSURE LEAK ALARM ENCOUNTERED. THIS FAILURE IS UNRELATED TO THE REPORTED ISSUE. THE DIRECT CAUSE WAS DAMAGED VSL TRANSDUCER TUBING. AN INTERNAL AND EXTERNAL INSPECTION WAS PERFORMED AND REVEALED NO ANOMALIES. THE VSR TRANSDUCER TUBING WAS REPLACED. AN EVALUATION OF THE DEVICE PNEUMATIC SYSTEM REVEALED NO LEAK AND ALL PRESSURES WERE CORRECT AND STABLE. PERFORMED ACCURACY CONFIRMATION AND TEMPERATURE VERIFICATION TEST AND PASSED. A SHORT SIMULATED THERAPY WAS PERFORMED SUCCESSFULLY. THE DEVICE WAS DETERMINED TO MEET THE SPECIFICATIONS RELATIVE TO THE COMPLAINT OF PATIENT PASSING AWAY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT), WHO PERFORMED PD THERAPY WITH A HOMECHOICE (HC) DEVICE, PASSED AWAY DUE TO AN UNKNOWN CAUSE. IT WAS UNKNOWN WHETHER THE PT WAS HOSPITALIZED PRIOR TO DEATH, HOWEVER, IT WAS REPORTED THAT THE PT WAS IN HOSPICE CARE AT THE TIME OF DEATH. IT WAS NOT REPORTED WHETHER THE PT WAS PERFORMING PD THERAPY WITH A HC AT THE TIME OF DEATH. IT WAS UNKNOWN IF AN AUTOPSY WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295508 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death DIANEAL PD4, 1.5% AMBUFLEX| DIANEAL PD4, 2.5% AMBUFLEX