BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3011719 · Received March 19, 2013

    Report

    Report Number
    1416980-2013-06640
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    January 6, 2013
    Report Date
    February 22, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR. THEREFORE, A SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL RELEVANT 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. PER REVIEW OF THE BATCH RECORDS FOR SUSPECTED H12G27079 AND H12G09010, NO NONCONFORMANCE REPORT WAS DOCUMENTED FOR THIS LOT. ALL RELEASE CRITERIA WERE MET FOR THE BUILD OF THE LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS, COINCIDENT WITH THERAPY FOR PERITONEAL DIALYSIS (PD). THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS, ON THE SAME DAY. THE THERAPIES WERE DISCONTINUED, HOWEVER THE TREATMENT WAS NOT REPORTED. TWELVE DAYS LATER THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND HAS RECOVERED. THIS IS REPORT 5 OF 6 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114701 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization HOMECHOICE| DIANEAL PD4 AMBUFLEX