BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3000008 · Received March 12, 2013

    Report

    Report Number
    1416980-2013-05896
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 15, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    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 BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR H12J15038 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONEAL DIALYSIS CATHETER INFECTION AND PERITONITIS. IT WAS UNKNOWN IF THE PD CATHETER INFECTION OCCURRED BEFORE OR AFTER THE PERITONITIS. THE PATIENT COULD NOT PROVIDE THE CAUSE OF THE INFECTION. THE PATIENT WAS HOSPITALIZED FOR THE EVENTS AND DISCHARGED 4 DAYS LATER. TREATMENT RENDERED FOR THE EVENTS INCLUDED ORAL DIFLUCAN 200 MILLIGRAM, 1 TABLET DAILY AND 2 TABLETS TO BE TAKEN ON HEMODIALYSIS DAYS FOR THIRTY DAYS. DURING HOSPITALIZATION, THE PATIENT'S PD CATHETER WAS REMOVED AND THE PATIENT WAS SWITCHED TO HEMODIALYSIS. THE PATIENT WAS NOT RETRAINED ON A PROPER ASEPTIC TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104191 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R