BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE, DOMESTIC 120V

    MDR report key: 1850558 · Received October 1, 2010

    Report

    Report Number
    1423500-2010-03995
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    August 20, 2010
    Report Date
    September 14, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)THE DEVICE IS AVAILABLE FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURING PLANT. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR EVALUATION AFTER THE CAREGIVER INFORMED BAXTER THE HOME PATIENT HAD PASSED AWAY. THE DEVICE WAS RECEIVED OPERATIONAL AND IN GOOD CONDITION. THE DEVICE PASSED THE HOMECHOICE RITE (RETURN INSTRUMENT TEST / EVALUATION), FUNCTIONAL AND ELECTRICAL TESTS AND WAS FUNCTIONING WITHIN SPECIFICATION. NO DEVICE FAILURE OR MALFUNCTION WAS IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE HOME PATIENT PASSING AWAY. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO EXCEPTION WAS OBSERVED DURING MANUFACTURING. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. ROOT CAUSE COULD NOT BE IDENTIFIED UPON COMPLETION OF BAXTER?S INVESTIGATION.

    Description of Event or Problem · 1

    THE CARE GIVER (CG) OF THE HOME PATIENT (HP) CALLED TO REPORT THAT THE HP PASSED AWAY ON (B)(6) 2010. THE CG SAID THAT IT HAD NOTHING TO DO WITH THERAPY. THE NURSE OF THE HP STATED THE CAUSE OF DEATH WAS CARDIO/PULMONARY INSUFFICIENCY. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR PERITONITIS PRIOR TO HIS DEATH. THE HP WAS SWITCHED FROM AUTOMATED PERITONEAL DIALYSIS TO HEMODIALYSIS AFTER THE PERITONITIS EPISODE AND REMAINED IN THE HOSPITAL UNTIL HE PASSED AWAY ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE, DOMESTIC 120V SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death| H| R