BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3854812 · Received June 6, 2014

    Report

    Report Number
    1416980-2014-18299
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    April 20, 2014
    Report Date
    May 13, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS IS THE SAME PATIENT AS COMPLAINTS (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBER H13K04070 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. AS THE SAMPLE WAS NOT RETURNED, A COMPLETE DEVICE ANALYSIS CANNOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS MANIFESTED BY STOMACH PAIN COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR THE EVENT, PD THERAPY WAS DISCONTINUED AND THE PATIENT STARTED HEMODIALYSIS (HD) THERAPY. DURING HOSPITALIZATION, THE PATIENT WAS TREATED WITH AN UNKNOWN ANTIBIOTIC (DOSE, ROUTE, FREQUENCY, AND DURATION NOT REPORTED) FOR PERITONITIS. ON AN UNKNOWN DATE, DURING HOSPITALIZATION, THE ANTIBIOTIC TREATMENT WAS DISCONTINUED. TEN DAYS AFTER HOSPITALIZATION, THE PATIENT WAS DISCHARGED. THE CAUSE OF PERITONITIS WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE EVENT OF PERITONITIS WAS ONGOING AND IMPROVED AND THE PATIENT WAS CONTINUING TO PERFORM HD THERAPY. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 4 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332809 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R DIANEAL PD4 AMBUFLEX, HOMECHOICE, MINICAP| FLEXICAP, CASSETTE