BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3021322 · Received March 26, 2013

    Report

    Report Number
    1416980-2013-07271
    Event Type
    Injury
    Date Received
    March 26, 2013
    Report Date
    March 5, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE OCCURRENCE DATE OF THIS EVENT IS UNKNOWN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. 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. SAME PATIENT AS (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: DUE TO THE INFORMATION RECEIVED, IT WAS DETERMINED THAT A BREACH IN ASEPTIC TECHNIQUE WAS THE CAUSE OF THE PERITONITIS. AS A RESULT, THE CAPD DISCONNECT Y-SET IS NO LONGER A SUSPECT PRODUCT. ALL FURTHER INVESTIGATIONS OF THIS EVENT WILL BE DOCUMENTED IN REPORT NUMBER 1416980-2013-07265.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. TREATMENT WAS NOT REPORTED. THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT. THIS IS REPORT 4 OF 4 FOR THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123551 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DIANEAL PD4 AMBUFLEX