BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE

    MDR report key: 2250170 · Received September 15, 2011

    Report

    Report Number
    1423500-2011-12269
    Event Type
    Death
    Date Received
    September 15, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 26, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER PRODUCT ANALYSIS LAB (PAL) RECEIVED THE DEVICE FOR EVALUATION. THE HOMECHOICE DEVICE PASSED THE RITE ELECTRICAL TEST. THE DEVICE FAILED THE RITE FUNCTIONAL TEST DUE TO ENCOUNTERING A RELOAD SET (RLS) 152 (2.5 PSI OR MORE LOSS IN VOLUMETRIC STANDARD RIGHT (VSR) IN 5 SECONDS). ASSIGNABLE CAUSE: DAMAGED AND LEAKING VSR TRANSDUCER TUBING (THIS ISSUE IS ADDRESSED IN A SEPARATE INVESTIGATION). TO MAKE THE DEVICE OPERATIONAL; THE TRANSDUCER TUBING WAS REPLACED AND THREE SIMULATED PATIENT THERAPIES WERE PERFORMED WITH NO PROBLEMS ENCOUNTERED. THE DEVICE PASSED MANUAL ACCURACY CONFIRMATION AND TEMPERATURE VERIFICATION PERFORMED AND WAS FOUND TO BE WITHIN SPECIFICATION. THE REPORTED DIFFICULTY OF HOME PATIENT PASSED AWAY WAS NOT CONFIRMED AND THE ASSIGNABLE CAUSE WAS NOT DETERMINED. PAL EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE HOME PATIENT PASSING AWAY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO THE BAXTER PRODUCT ANALYSIS LAB (PAL) FOR EVALUATION. SHOULD AN EVALUATION BE PERFORMED OR ADDITIONAL INFORMATION RECEIVED A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CAREGIVER (CG) CALLED BAXTER TO REPORT THE HOME PATIENT (HP) PASSED AWAY ON (B)(6) 2011. FOLLOW UP INFORMATION WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE. THE US FACILITY NURSE REPORTED THE FEMALE PATIENT EXPIRED DUE TO MYOCARDIAL INFARCTION COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2011, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS MYOCARDIAL INFARCTION. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED. DIANEAL THERAPY WAS ONGOING AT THE TIME OF DEATH. THE NURSE REPORTED THAT THE MYOCARDIAL INFARCTION WAS UNRELATED TO DIANEAL THERAPY. ON (B)(6) 2011, REVIEW OF THE DEVICE EVENT LOGS REVEALED AN OVERFILL EVENT OCCURRED WITHIN 48 HOURS OF PATIENT DEATH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| O DIANEAL LOW CAL, SINGLE BAG DEXTROSE (B)(4)| DIANEAL LOW CAL, SINGLE BAG DEXTROSE (B)(4)| DIANEAL LOW CAL, SINGLE BAG DEXTROSE (B)(4)| DIANEAL LOW CAL, SINGLE BAG DEXTROSE (B)(4)| DIANEAL LOW CAL, SINGLE BAG DEXTROSE (B)(4)| DIANEAL LOW CAL, SINGLE BAG DEXTROSE (B)(4)