BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOME CHOICE PRO

    MDR report key: 2141854 · Received June 27, 2011

    Report

    Report Number
    1423500-2011-08417
    Event Type
    Death
    Date Received
    June 27, 2011
    Date of Event
    April 23, 2011
    Report Date
    April 23, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    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). INFORMATION ERRONEOUSLY OMITTED FROM THE FIRST FOLLOW-UP MEDWATCH. ADDITIONAL INFORMATION: A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS REPORTED PROBLEM WITH THIS PUMP.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF FURTHER INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE WAS RETURNED AND EVALUATED BY THE BAXTER PRODUCT ANALYSIS LAB (B)(4). THE DEVICE WAS DETERMINED TO MEET FUNCTIONAL AND ELECTRICAL PERFORMANCE SPECIFICATION REQUIREMENTS PER RITE TESTING. THE DEVICE PASSED BOTH THE HOMECHOICE RETURN INSTRUMENT TEST / EVALUATION (RITE) ELECTRICAL TEST AND THE RITE FUNCTIONAL TEST. REVIEW OF THE DEVICE LOGS REVEALED A DRAIN VOLUME OF 4,527 ML HAD OCCURRED @ 6:23AM DURING CYCLE 5 OF 5 ON (B)(6) 2011, WHICH WAS 181% OF THE LARGEST PRESCRIBED FILL VOLUME OF 2500 ML AND MET IIPV CRITERIA. AN ADDITIONAL THERAPY WAS SUCCESSFULLY COMPLETED BY THE USER USING THE DEVICE ON (B)(6) 2011 (ENDING THE MORNING OF (B)(6) 2011). A 3RD THERAPY WAS STARTED USING THE DEVICE THE NIGHT OF (B)(6) 2011 AT 10:30PM; HOWEVER, THE THERAPY WAS NOT COMPLETED. THE CYCLER WAS TURNED OFF DURING DWELL 4 OF 5 ON (B)(6) 2011 @ 5:10AM AND NO FURTHER THERAPIES WERE PERFORMED WITH THE DEVICE PRIOR TO ITS RETURN TO THE PAL FOR EVALUATION. EVALUATION OF THE DEVICE REVEALED NO DEVICE FAILURE OR MALFUNCTION THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE IIPV ON (B)(6) 2011 OR THE PATIENT PASSING AWAY (B)(6) 2011. NO ISSUES WERE IDENTIFIED DURING REVIEW OF THE PREVIOUS DEVICE SERVICE RECORD THAT MAY HAVE CONTRIBUTED TO THE ISSUES OF IIPV OR THE PATIENT PASSING AWAY. THE ASSIGNABLE CAUSE OF THE IIPV FOUND IN THE LOGS WAS DETERMINED TO BE: INSUFFICIENT DRAIN-USE ERROR, TIDAL UF REMOVAL SET TOO LOW @ 250 ML. THE ASSIGNABLE CAUSE OF THE PATIENT PASSING AWAY WAS UNDETERMINED VIA DEVICE EVALUATION. THE DEVICE WAS SUBSEQUENTLY FORWARDED TO SERVICE. THE CURRENT LABELING FOR THE HOMECHOICE/HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE WAS FOUND TO BE SUFFICIENT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM FOR IIPV. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RTB-CAPA-(B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011 A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A PATIENT DEATH. PER THE INITIAL REPORT, THE CAREGIVER (CG) STATED THE HOME PATIENT (HP) PASSED AWAY. BAXTER'S PRODUCT SURVEILLANCE RECEIVED FOLLOW-UP INFORMATION FROM GLOBAL PHARMACOVIGILANCE. THE HP EXPIRED ON (B)(6) 2011 FROM A MYOCARDIAL INFARCTION. PER THE REPORTER, THE DEATH WAS NOT RELATED TO ANY OF THE BAXTER PD SOLUTIONS IN USE BY THE HP. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death DIANEAL PD4 AMBUFLEX| HOME CHOICE