BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE PRO

    MDR report key: 2180242 · Received July 27, 2011

    Report

    Report Number
    1423500-2011-09706
    Event Type
    Death
    Date Received
    July 27, 2011
    Date of Event
    June 29, 2011
    Report Date
    July 1, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED IN THE BAXTER PRODUCT ANALYSIS LAB (PAL) OPERATIONAL AND IN GOOD CONDITION. THE DEVICE PASSED THE HOMECHOICE RITE (RETURN INSTRUMENT TEST / EVALUATION), FUNCTIONAL AND ELECTRICAL TESTS AND WAS FUNCTIONING WITHIN SPECIFICATION. THERE WERE NO PROBLEMS FOUND DURING AN INTERNAL INSPECTION OF THE DEVICE. A REVIEW OF THE DEVICE LOGS REVEALED NO ANOMALIES AND NO DRAIN OR ULTRAFILTRATION (UF) VOLUMES THAT MEET THE IIPV (INCREASED INTRA-PERITONEAL VOLUME) CRITERIA. NO ISSUES WERE IDENTIFIED DURING REVIEW OF THE DEVICE'S SERVICE HISTORY RECORD. PAL EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED TO THE BAXTER PRODUCT ANALYSIS LAB (PAL) FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION AND IF ADDITIONAL INFORMATION RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A PATIENT DEATH. PER THE INITIAL REPORT, THE CAREGIVER (CG) REPORTED THE HOME PATIENT (HP) PASSED AWAY 2 DAYS AGO. THE CG STATED THE CAUSE OF DEATH WAS BELIEVED TO BE A MASSIVE HEART ATTACK. THE CG STATED THE HP HAD SEVERAL STINTS AND HAD LOST A LEG AND FOOT. THE CG STATED THE HP HAD SEVERAL HEALTH ISSUES. DURING A FOLLOW UP CALL ON (B)(6) 2011 THE FACILITY NURSE INDICATED: THIS WAS CONSIDERED A CORONER'S CASE BECAUSE THE PATIENT EXPIRED AT HOME. SHE SPOKE WITH THE MEDICAL EXAMINER AND WAS ADVISED THERE WAS NO EVIDENCE OF FOUL PLAY. THE PATIENT REPORTEDLY EXPERIENCED A HEART ATTACK AND EXPIRED. NO AUTOPSY WAS PERFORMED. THE PATIENT REPORTEDLY HAD BEEN ADVISED TO HAVE HEART SURGERY AND SHE DECLINED. THE NURSE INDICATED THERE WAS NO EVIDENCE THAT THE BAXTER DEVICE OR SOLUTIONS WERE RELATED TO THE EVENT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death| O 4.25% LO/CAL 6L/6L DNL| 1.5% LO/CAL UB 2.5L/3L DN| DIANEAL LOW CA 2.5% 6L/^L| 2.5% LO/CAL 6L/6L DNL| EXTRANEAL ICODEXTRIN 2L/3L| DIANEAL LOW CA 1.5% 6L/6L| EXTRANEAL PD-2 2L/3L SING| DIANEAL LOW CA 4.25% 6L/6L| 2.5% LO/CAL UB 2.5L/3L DN| 1.5% LO/CAL 6L/6L DNL| 4.25% LO/CAL UB 2.5L/3L DN