BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3251309 · Received July 29, 2013

    Report

    Report Number
    1416980-2013-19991
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    June 18, 2013
    Report Date
    July 3, 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). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED H12J11037, H12K09112, H13A04047, AND H13C05032 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED. THIS IS THE SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) EXPERIENCED PERITONITIS. FOUR DAYS LATER THE PATIENT WAS HOSPITALIZED FOR THE EVENT. ON AN UNKNOWN DATE, THE PT WAS TREATED WITH ANTIBIOTICS (TYPE, DOSE, FREQUENCY, AND ROUTE UNKNOWN). ON AN UNKNOWN DATE, DURING HOSPITALIZATION, THE PT HAD A PD CATHETER REPOSITION SURGERY. TEN DAYS AFTER BEING ADMITTED, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED "PD CATHETER TIED AROUND INTESTINES." ON THE SAME DATE, THE PATIENT'S CATHETER WAS REMOVED. ON AN UNREPORTED DATE THE PT BEGAN HEMODIALYSIS. AT THE TIME OF THIS REPORTED THE PT WAS RECOVERED. THIS IS REPORT 3 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353976 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R DIANEAL 1.5%, AMBUFLEX, LOW CALCIUM| HOMECHOICE AUTOMATED PD SET WITH CASSETTE| DIANEAL 2.5%, AMBUFLEX, LOW CALCIUM| MINICAP| EXTRANEAL