BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE

    MDR report key: 2180003 · Received July 27, 2011

    Report

    Report Number
    1423500-2011-09705
    Event Type
    Death
    Date Received
    July 27, 2011
    Date of Event
    June 25, 2011
    Report Date
    June 30, 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 HAS BEEN REQUESTED TO BE RETURNED TO THE BAXTER PRODUCT ANALYSIS LAB (PAL) FOR EVALUATION. SHOULD THE DEVICE BE RECEIVED AND AN EVALUATION PERFORMED OR IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER PRODUCT ANALYSIS LAB (PAL) RECEIVED THE DEVICE INOPERATIVE FOR NO DISPLAY BUT IN GOOD CONDITION. THE DEVICE FAILED THE HOMECHOICE RITE (RETURN INSTRUMENT TEST AND EVALUATION) FUNCTIONAL TEST FOR NO DISPLAY BUT PASSED THE RITE ELECTRICAL TEST. THE PRODUCT ANALYSIS LAB EVALUATED THE DEVICE. THERE WERE NO PROBLEMS FOUND DURING AN INTERNAL INSPECTION. THE DISPLAY MODULE WAS REPLACED WITH THE TEST ARTICLE AND THE DISPLAY FUNCTIONED PROPERLY. THREE SIMULATED PATIENT THERAPIES WERE PERFORMED AND COMPLETED SUCCESSFULLY. ACCURACY CONFIRMATION AND TEMPERATURE VERIFICATION TESTS WERE PERFORMED AND PASSED. 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. THE ASSIGNABLE CAUSE FOR RITE TEST FAILURE - RECEIVED INOPERATIVE FOR NO DISPLAY WAS DETERMINED TO BE AN INOPERATIVE DISPLAY. NO DEVICE FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT DEATH. NO ISSUES WERE IDENTIFIED DURING REVIEW OF THE DEVICE'S SERVICE HISTORY RECORD.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A PATIENT DEATH. THE PATIENT REPORTEDLY EXPIRED ON (B)(6) 2011 FROM A STROKE. INFORMATION RECEIVED FROM GLOBAL PHARMACOVIGILANCE INDICATES: THIS IS A SPONTANEOUS CONSUMER REPORT BY A NURSE FROM THE USA OF A FATAL STROKE IN A FEMALE COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY. IT WAS UNREPORTED IF AN AUTOPSY WAS PERFORMED. DIANEAL THERAPY WAS ONGOING UNTIL THE DATE OF DEATH. ON (B)(6) 2011, THE NURSE CONFIRMED THE CAUSE OF DEATH WAS STROKE (ONSET NOT REPORTED) AS REPORTED BY THE CONSUMER. THE NURSE REPORTED THAT THE DEATH WAS SUDDEN. THE NURSE DID NOT PROVIDE AN OPINION OF CAUSALITY. THE NURSE DECLINED TO PROVIDE ADDITIONAL INFORMATION. CONCOMITANT MEDICATIONS WERE NOT REPORTED.

    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 68 YR Death| O DIANEAL LOW CA 2.5% 6L/6L| 2.5% LO/CAL UB 2L/2L DIANEAL| 1.5% LO/CAL UB 2L/2L DIANEAL| DIANEAL LOW CA 1.5% 6L/6L| DIANEAL LOW CA 1.5% 5L/5L| 4.25% LO/CAL UB 2L/2L DIANEAL| EXTRANEAL ICODEXTRIN 2L/3L| DIANEAL LOW CA 4.25% 6L/6L