BEUDAMED
    FDA Adverse Event Death Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3092359 · Received May 3, 2013

    Report

    Report Number
    1416980-2013-11252
    Event Type
    Death
    Date Received
    May 3, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 10, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(6) 2013, THE PATIENT DIED DUE TO END STAGE RENAL DISEASE. DIANEAL THERAPY WAS ONGOING UNTIL THE TIME OF DEATH. THE NURSE WAS CONTACTED AND DECLINED TO PROVIDE INFORMATION. A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOTS H12F07040, H12I05048, H12K07082, H12I27059, H12G19068, H12K28039, H12L18046 AND H12J15038. NO ISSUES WERE NOTED DURING THE MANUFACTURING PROCESS. AN EXCEPTION WAS NOTED FOR H12J15038 BUT DOES NOT INDICATE ANY ISSUES RELATED TO THE COMPLAINT.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED AND WAS HOSPITALIZED FOR PERITONITIS COINCIDENT WITH THERAPY FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, THERAPY WAS DISCONTINUED. THE CAUSE OF PERITONITIS WAS UNKNOWN. TREATMENT WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT HAD NOT YET RECOVERED FROM THE EVENT OF PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195276 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death| H HOMECHOICE, DIANEAL PD4 AMBUFLEX