BEUDAMED
    FDA Adverse Event Death Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2974235 · Received February 22, 2013

    Report

    Report Number
    1416980-2013-04460
    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
    K882498
    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). THIS COMPLAINT FOR PERITONITIS - NO MALFUNCTION OR USE ERROR IS NOT CONFIRMED BECAUSE NO SAMPLES WERE RETURNED TO BAXTER. REVIEWS OF MANUFACTURING RECORDS REVEALED NO ISSUES OR DEVIATIONS FROM STANDARD PROCEDURE. THE USER DID NOT DESCRIBE ANY TYPES OF USE ERRORS THAT MIGHT HAVE CAUSED POTENTIAL CONTAMINATION. A ROOT CAUSE WAS NOT IDENTIFIED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    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 WITHDRAW 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
    78844 MINICAP TRANSFER 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