BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE

    MDR report key: 2394571 · Received January 3, 2012

    Report

    Report Number
    1423500-2012-00052
    Event Type
    Death
    Date Received
    January 3, 2012
    Date of Event
    November 9, 2011
    Report Date
    November 9, 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). THE DEVICE HAS BEEN REQUESTED FOR RETURN TO THE BAXTER PRODUCT ANALYSIS LAB FOR EVALUATION. SHOULD THE DEVICE BE RECEIVED AND AN EVALUATION COMPLETED OR ADDITIONAL INFORMATION RECEIVED , A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED AND EVALUATED BY THE BAXTER PRODUCT ANALYSIS LABORATORY (PAL). THE DEVICE PASSED BOTH THE HOMECHOICE RITE ELECTRICAL TEST AND THE HOMECHOICE RITE FUNCTIONAL TEST. A REVIEW OF THE DEVICE EVENT HISTORY LOGS REVEALED NO FAILURE, MALFUNCTION OR IIPV EVENTS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. A DESIGN HISTORY REVIEW WAS PERFORMED AND NO ABNORMALITY WAS OBSERVED. A TWO (2) YEAR REVIEW OF THE SERVICE HISTORY FOR REVEALED THE DEVICE WAS NOT PREVIOUSLY RETURNED FOR ANY PRIOR SERVICING. THE REPORTED ISSUE WAS NOT CONFIRMED AND THE ASSIGNABLE CAUSE WAS NOT DETERMINED. THE DEVICE FUNCTIONED PROPERLY PER THE RITE (RETURNED INSTRUMENT TEST EVALUATION) SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 1

    INITIALLY, BAXTER GLOBAL PHARMACOVIGILANCE (GPV) RECEIVED THE FOLLOWING INFORMATION FROM THE DAUGHTER OF THE PERITONEAL DIALYSIS (PD) HOME PATIENT (HP). THE DAUGHTER REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2011. THE CAUSE OF DEATH WAS REPORTED AS "CONGESTIVE HEART FAILURE." ON (B)(4) 2011, GPV SPOKE WITH A REGISTERED NURSE (RN) TO FOLLOW UP ON THE REPORT. THE RN STATED THIS WAS THE FIRST THEY HAD HEARD THE PATIENT PASSING AWAY. ON (B)(4) 2011, GPV CONTACTED ANOTHER RN TO REQUEST FURTHER INFORMATION. THE RN CONFIRMED THE PATIENT'S DATE OF DEATH WAS (B)(6) 2011, BUT COULD NOT CONFIRM THE CAUSE OF DEATH AS "CONGESTIVE HEART FAILURE," AS REPORTED BY THE CONSUMER. THE CAUSE OF DEATH WAS UNKNOWN. THE RN STATED THE PATIENT DIED AT HOME AND THAT THE PATIENT HAD A HISTORY OF HEART DISEASE. THE RN STATED THE ADVERSE EVENT OF DEATH WITH THE CAUSE OF DEATH UNKNOWN WAS NOT RELATED TO PD THERAPY. ON 27DEC2011, PS CONTACTED THE PERITONEAL DIALYSIS NURSE (PDN) TO INQUIRE IF FURTHER INFORMATION HAD BECOME AVAILABLE. THE PDN STATED THE CAUSE OF THE PATIENT'S DEATH IS STILL UNKNOWN TO THEM. SHE CONFIRMED THAT THEY WERE NEVER INFORMED OF THE PATIENT PASSING AWAY AND STATED THAT THE ONLY INFORMATION THEY HAVE ON THE PATIENT'S PASSING IS WHAT WAS RECEIVED WHEN BAXTER INITIALLY CONTACTED THEM TO FOLLOW UP ON THE REPORT. THE RN DECLINED THE AVAILABILITY OF ANY FURTHER INFORMATION REGARDING THE EVENT.

    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 79 YR Death