BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3873044 · Received June 13, 2014

    Report

    Report Number
    1416980-2014-18946
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 20, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT INVOLVES THE SAME PATIENT AS IN (B)(4). THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD THE DEVICE BE RETURNED OR ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER(S) H13J04064 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED BACTERIAL PERITONITIS MANIFESTED BY CLOUDY EFFLUENT BAG COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE NEXT DAY, THE PATIENT STARTED TREATMENT WITH VANCOMYCIN (DOSE, ROUTE, FREQUENCY, AND DURATION NOT REPORTED) AND GENTAMICIN (DOSE, ROUTE, FREQUENCY, AND DURATION NOT REPORTED) AS A PROPHYLAXIS TREATMENT FOR PERITONITIS. ON THE SAME DAY, TREATMENT WITH VANCOMYCIN AND GENTAMYCIN WAS STOPPED. THE CAUSE OF THE PERITONITIS EVENT WAS UNKNOWN. THREE DAYS AFTER THE ONSET OF PERITONITIS, THE PATIENT WAS HOSPITALIZED. FURTHER TREATMENT FOR THE PERITONITIS EVENT WAS NOT REPORTED. HOSPITALIZATION WAS REPORTED AS ONGOING. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM PERITONITIS. ON THE DAY OF HOSPITALIZATION, DIANEAL THERAPY WAS DISCONTINUED DUE TO THE PERITONITIS EVENT AND HEMODIALYSIS WAS STARTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 4 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349238 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R MINICAP, FLEXICAP| CASSETTE, DIANEAL 2.5% LOW CALCIUM ULTRABAG PD4| CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD)