BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE PRO

    MDR report key: 2503840 · Received March 26, 2012

    Report

    Report Number
    1423500-2012-07071
    Event Type
    Death
    Date Received
    March 26, 2012
    Date of Event
    March 1, 2012
    Report Date
    March 3, 2012
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER PRODUCT ANALYSIS LAB (PAL). EVALUATION RESULTS INDICATE: NO FAILURE, MALFUNCTION OR INCREASED INTRAPERITONEAL VOLUME (IIPV) EVENTS WERE FOUND IN THE EVENT HISTORY LOG REVIEW THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE PAL EVALUATED THE DEVICE AND NO DEVICE FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE HOME PATIENT PASSING AWAY. THE REPORTED ISSUE WAS NOT CONFIRMED. THE ASSIGNABLE CAUSE WAS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS BEING RETURNED FOR EVALUATION. BAXTER IS ATTEMPTING TO OBTAIN ADDITIONAL CLINICAL INFORMATION RELATED TO THIS INCIDENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER (B)(4) TECHNICAL SERVICE CENTER REGARDING THE DEATH OF A HOME PATIENT (HP) THAT OCCURRED WHILE THE PATIENT WAS ON THE HOMECHOICE (HC) DEVICE. A (B)(6) POLICE OFFICER STATED THAT HE WAS CALLING FROM THE HOME OF THE PATIENT. THE PATIENT HAD EXPIRED. THE OFFICER INDICATED THE CORONER REQUESTED THE MACHINE BE EVALUATED TO BE SURE THAT IT'S WORKING PROPERLY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ARRANGED FOR PICKUP. THE OFFICER DID NOT GIVE ANY FURTHER INFORMATION. REPORTEDLY THE PATIENT WAS IN DRAIN 5 OF 6 WHEN HE EXPIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O