BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXTENSION SET

    MDR report key: 2974161 · Received February 22, 2013

    Report

    Report Number
    1416980-2013-04457
    Event Type
    Death
    Date Received
    February 22, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 28, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K925403
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT WAS NOT CONFIRMED AND THE CAUSE WAS NOT IDENTIFIED BECAUSE A DEVICE MALFUNCTION WAS NOT IDENTIFIED, THE SAMPLE WAS NOT RETURNED FOR EVALUATION AND THE HOME PATIENT DID NOT REPORT ANY TYPE OF USE ERROR THAT MIGHT HAVE LED TO THE ISSUE. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOTS H12I13059 AND H12D27068 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE.

    Description of Event or Problem · 1

    THIS IS A REPORT OF PATIENT WITH PERITONITIS, FATAL VOLUNTARY WITHDRAWAL OF PERITONEAL DIALYSIS (PD) THERAPY, AND FATAL HEART FAILURE. IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS AND HEART FAILURE. THE CAUSE OF THE PERITONITIS WAS UNKNOWN BUT THE PATIENT DID HAVE A PAST MEDICAL HISTORY OF HEART FAILURE. TREATMENT WAS NOT REPORTED. THE PATIENT VOLUNTARILY WITHDREW FROM PD THERAPY PRIOR TO DEATH. THE REPORTED CAUSE OF DEATH WAS HEART FAILURE AND VOLUNTARY WITHDRAWAL OF PD THERAPY. IT WAS UNKNOWN IF THE PATIENT'S CONDITION OF HEART FAILURE HAD WORSENED PRIOR TO DEATH. IT WAS NOT REPORTED WHETHER AN AUTOPSY WAS PERFORMED. THE NURSE DID NOT HAVE ANY ADDITIONAL INFORMATION REGARDING THIS EVENT AS THE PATIENT WAS NO LONGER ON PD THERAPY AT THE TIME OF DEATH. SAME PATIENT AS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78325 EXTENSION SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death DIANEAL LOW CALCIUM| HOMECHOICE