BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3873565 · Received June 14, 2014

    Report

    Report Number
    1416980-2014-19066
    Event Type
    Injury
    Date Received
    June 14, 2014
    Date of Event
    May 17, 2014
    Report Date
    May 21, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H13L02031 AND H14A07064 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.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WILL BE PERFORMED FOR THE POTENTIALLY ASSOCIATED LOT NUMBERS H13L02031 AND H14A07064 IF ANY RELEVANT INFORMATION IS OBTAINED THAT IS RELATED TO THE REPORTED EVENT; A SUPPLEMENTAL REPORT 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 EXPERIENCED PERITONITIS COINCIDENT WITH THERAPY FOR PERITONEAL DIALYSIS. PD THERAPY WAS REPORTED TO BE ONGOING. ON THE SAME DAY AS ONSET THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS EVENT. IT WAS REPORTED THAT THE PERITONITIS WAS MANIFESTED BY ABDOMINAL PAIN AND CLOUDY EFFLUENT. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS TREATED WITH VANCOMYCIN 2 GRAMS EVERY 5 DAYS (ROUTE NOT REPORTED) AND GENTAMYCIN 70 MILLIGRAMS (FREQUENCY AND ROUTE NOT REPORTED). THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TWO DAYS LATER. AT THE TIME OF THIS REPORT ANTIBIOTIC THERAPY WAS REPORTED TO BE ONGOING AND THE PATIENT WAS REPORTED TO BE RECOVERING FROM THE PERITONITIS. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS IS REPORT 1 OF 2 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351742 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R DIANEAL PD4 2.5% ULTRABAG, EXTRANEAL VIAFLEX| MINICAP, HOMECHOICE