BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE

    MDR report key: 2437284 · Received February 2, 2012

    Report

    Report Number
    1423500-2012-02353
    Event Type
    Death
    Date Received
    February 2, 2012
    Date of Event
    January 10, 2012
    Report Date
    January 11, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT HAD PASSED AWAY ON (B)(6) 2012 OF UNKNOWN CAUSES. THE RN STATED THE DEATH WAS NOT RELATED TO DIANEAL THERAPY. A REVIEW OF THE DEVICE'S LOGS REVEALED NO FAILURE OR MALFUNCTION THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. HOWEVER, AN INSTANCE OF INCREASED INTRAPERITONEAL VOLUME WAS REVEALED IN THE DEVICE'S LOGS AND WAS ADDRESSED IN MDR #1423500-2012-03991. HOMECHOICE SN (B)(4) WAS EVALUATED BY PAL FOR THE REPORTED DIFFICULTY OF HOME PATIENT PASSED AWAY. 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. A TWO YEAR REVIEW OF THE DEVICE SERVICE HISTORY REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY OF THE PATIENT PASSING AWAY. REVIEW OF THE DEVICE HISTORY REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY OF THE PATIENT PASSING AWAY. THE REPORTED ISSUE WITH REGARDS TO THE DEVICE WAS NOT CONFIRMED. THE ASSIGNABLE CAUSE WAS UNDETERMINED.

    Description of Event or Problem · 1

    A REGISTERED NURSE (RN) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A PATIENT DEATH. THE RN WANTED THE RESULTS OF THE DEVICE EVALUATION TO DETERMINE IF THERE WAS AN ISSUE WITH THE MACHINE. GLOBAL PHARMACOVIGILANCE SENT FOLLOW UP INFORMATION REGARDING THE PATIENT'S DEATH. THE REGISTERED NURSE REPORTED THE FOLLOWING TO HOMECARE SERVICES. THE PATIENT PASSED AWAY ON (B)(6) 2012. THE CAUSE OF DEATH WAS UNKNOWN. THE RN DID NOT BELIEVE THE EVENT WAS RELATED TO ANY OF THE BAXTER PD SOLUTIONS THE PATIENT WAS ON. GLOBAL PHARMACOVIGILANCE OBTAINED ADDITIONAL INFORMATION ON (B)(6) 2012, FROM THE REGISTERED NURSE (RN). THE RN STATED THE PATIENT DIED IN HIS SLEEP. NO AUTOPSY WAS DONE AND THE CAUSE OF DEATH WAS UNKNOWN. THE RN STATED THE DEATH WAS NOT RELATED TO DIANEAL THERAPY.

    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 69 YR Death DIANEAL LOW CA 2.5% 5L/5L| LOW CA 2.5% 2.5L/3L UB DIANEAL| DIANEAL LOW CA 1.5% 5L/5L| DIANEAL LOW CA 4.25% 5L/5| LOW CA 1.5% 2.5L/3L UB DIANEAL| LOW CA 4.25% 2.5/3L UB DIANEAL