BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3160009 · Received June 10, 2013

    Report

    Report Number
    1416980-2013-14869
    Event Type
    Injury
    Date Received
    June 10, 2013
    Report Date
    May 20, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE OCCURRENCE DATE OF THIS EVENT IS UNKNOWN, HOWEVER, IT WAS REPORTED THE EVENT "OOK" PLACE IN (B)(6) 2013. 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. A BATCH REVIEW WAS CONDUCTED FOR THE POTENTIALLY ASSOCIATED LOT NUMBER H12I06079 AND H12L13070. NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 3 OF 3. THIS IS A REPORT OF PERITONITIS AND RASH IN A PATIENT COINCIDENT WITH DIANEAL THERAPIES FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, DIANEAL THERAPIES WERE DISCONTINUED AND THE PATIENT WAS SWITCHED TO HEMODIALYSIS. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT BROKE OUT IN A RASH. THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. THE CAUSE OF PERITONITIS WAS UNKNOWN. THE PATIENT STATED THAT THE SOLUTION, WHICH WAS INITIALLY CLEAR, TURNED BROWN AND TURNED WHITE. THE TREATMENT RENDERED FOR THE EVENTS WAS NOT REPORTED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT RECOVERED FROM THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259297 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization HOMECHOICE, DIANEAL PD2 AMBUFLEX