BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE

    MDR report key: 2485494 · Received March 9, 2012

    Report

    Report Number
    1423500-2012-05864
    Event Type
    Death
    Date Received
    March 9, 2012
    Date of Event
    February 11, 2012
    Report Date
    February 28, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS REPORTED TO BE AVAILABLE BUT HAS NOT BEEN RECEIVED FOR EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE OR THE DEVICE IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT HAD PASSED AWAY ON (B)(6) 2012. THE DEVICE WAS RETURNED FOR EVALUATION. A REVIEW OF THE DEVICES LOGS REVEALED NO FAILURE, MALFUNCTION OR IIPV EVENTS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT. THE DEVICE PASSED BOTH THE HOMECHOICE RITE ELECTRICAL TEST AND THE HOMECHOICE RITE FUNCTIONAL TEST AND WAS DETERMINED TO MEET PERFORMANCE SPECIFICATION REQUIREMENTS PER RITE TESTING. THE PAL EVALUATED THE DEVICE AND NO FAILURES OR MALFUNCTIONS WERE IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE HOME PATIENT PASSING AWAY. THE ISSUE WITH REGARDS TO THE DEVICE WAS NOT CONFIRMED. THE ASSIGNABLE CAUSE WAS UNDETERMINED. REVIEW OF THE SERVICE HISTORY FOR PRODUCT (B)(4), SERIAL NUMBER (B)(4), REVEALED THERE HAS BEEN NO PREVIOUS SERVICE ACTIVITY ON THIS DEVICE. THE DEVICE WAS SHIPPED TO THE CUSTOMER NEW AND HAS NOT BEEN PREVIOUSLY SERVICED/REFURBISHED. THE DEVICE HISTORY RECORD REVIEW DETERMINED NO ABNORMALITY WAS OBSERVED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CAREGIVER (CG) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT THE PATIENT PASSED AWAY. NO ALLEGATION WAS MADE AGAINST ANY BAXTER PRODUCT. THE RN REPORTED THAT THE PATIENT PASSED AWAY (CAUSE OF DEATH NOT PROVIDED). THE RN DECLINED TO PROVIDE FURTHER INFORMATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death (B)(4) LOW CA (B)(4) 2.5L/3L UB DIANEAL| (B)(4) LOW CA (B)(4) 2.5L/3L UB DIANEAL| (B)(4) DIANEAL LOW CA (B)(4) 2/3L| (B)(4) DIANEAL LOW CA (B)(4) 6L/6L| (B)(4) LOW CA (B)(4) 2.5/3L UB DIANEAL| (B)(4) DIANEAL LOW CA (B)(4) 6L/6L| (B)(4) DIANEAL LOW CA (B)(4) 6L/6L| (B)(4) DIANEAL LOW CA (B)(4) 2L/3L