BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3873212 · Received June 13, 2014

    Report

    Report Number
    1416980-2014-18985
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 17, 2014
    Report Date
    May 20, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR POTENTIALLY ASSOCIATED LOT NUMBERS H14A27021, H13L02031, AND H14B28035 WAS PERFORMED 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 FOR EVALUATION, A COMPLETE DEVICE ANALYSIS COULD NOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT CODE AND LOT NUMBER OF THIS PRODUCT ARE UNKNOWN; HOWEVER, THE BRAND NAME AND 510K NUMBER OF THE POTENTIAL PRODUCT CODES AND LOTS RECEIVED BY THE CLINIC ARE THE SAME; THEREFORE, THEY WERE PROVIDED.   (B)(4). 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 PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PERITONITIS WAS MANIFESTED BY THE PATIENT¿S CATHETER LOOKING CLOUDY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS. THE PATIENT WAS TREATED WITH CEFAZOLIN (1GM DAILY FOR 2 WEEKS, ROUTE NOT REPORTED) AND CEFTAZADIME (1GM DAILY FOR 2 WEEKS, ROUTE NOT REPORTED). THE PATIENT RECOVERED FROM THE PERITONITIS. DIANEAL THERAPIES WERE ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 4 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350385 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention HOMECHOICE AUTOMATED PD SET WITH CASSETTE| HOMECHOICE, MINICAP, FLEXICAP| DIANEAL PD4 1.5% AND 2.5% AMBUFLEX