BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3005368 · Received March 14, 2013

    Report

    Report Number
    1416980-2013-06235
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 20, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PROBLEM WAS NOT CONFIRMED, AND THE CAUSE WAS NOT DETERMINED BECAUSE THERE WAS NO SAMPLE RETURNED TO BAXTER FOR EVALUATION. A BATCH REVIEW COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT AVAILABLE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). AN INTERNAL INVESTIGATION IS CURRENTLY UNDER WAY, HOWEVER HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) WAS CONTACTED IN ORDER TO OBTAIN ADDITIONAL INFORMATION REGARDING THE HOME PATIENT?S (HP) REPORT OF INFECTION. THE PDRN STATED THAT THE HP HAD EXPERIENCED AN UNINTENTIONAL DICONNECTION OF THE TRANSFER SET FROM THE TITANIUM ADAPTER. THE HP THEN RECONNECTED THEM TOGETHER AND DID NOT INFORM THE CLINIC OF THE EVENT UNTIL A COUPLE DAYS LATER. THE HP UNDERWENT OUTPATIENT SURGERY TO ADJUST THE PD CATHETER AND CLOUDY EFFLUENT WAS NOTED. ON THE SAME DAY THE HP WAS DIAGNOSED WITH PERITONITIS. THE HP WAS NOT HOSPITALIZED FOR THE EVENT. THE HP IS BEING TREATED WITH VANCOMYCIN INTRAPERITONEALLY (IP) (DOSE AND FREQUENCY NOT REPORTED). THE HP RECOVERED FROM THE PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107571 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention HOMECHOICE| EXTRANEAL| DIANEAL LOW CA