BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3953327 · Received July 23, 2014

    Report

    Report Number
    1416980-2014-23887
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 30, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H13J04064 AND H14D01012 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. THIS IS SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS HOSPITALIZED FOR THE EVENT AND TREATED WITH BACTRIM ORALLY (DOSAGE AND FREQUENCY NOT REPORTED), INTRAVENOUS (IV) GENTAMYCIN (DOSAGE AND FREQUENCY NOT REPORTED) AND IV TOBRAMYCIN (DOSAGE AND FREQUENCY NOT REPORTED). AT THE TIME OF THIS REPORT, THE PATIENT HAD NOT YET RECOVERED FROM THE PERITONITIS. PERITONEAL DIALYSIS THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THIS TIME. THIS IS REPORT 4 OF 4 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431143 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R HOMECHOICE, MINICAP, FLEXICAP| DIANEAL 2.5% PD4 AMBUFLEX| HOMECHOICE AUTOMATED PD SET WITH CASSETTE| DIANEAL 2.5% PD4 ULTRABAG