BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3192000 · Received June 27, 2013

    Report

    Report Number
    1416980-2013-16517
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 4, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS NOT CONFIRMED AND THE CAUSE WAS NOT IDENTIFIED BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION. IT WAS REPORTED THAT THE CUSTOMER USED AN ALCOHOL CONTAINING DISINFECTANT TO CLEAN THE TRANSFERS. THE CURRENT INSTRUCTIONS FOR THIS TRANSFER SET INSTRUCT THE USER TO NOT APPLY HYDROGEN PEROXIDE, ALCOHOL OR ANTISEPTIC AGENTS CONTAINING ALCOHOL TO THE CONNECTORS. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER H12D16046 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHITE ROLLER CLAMP OF A TRANSFER SET BROKE DURING USE ON A PATIENT. THERE WAS A CLICKING SOUND AND THE LOCK MECHANISM OF THE TRANSFER SET STOPPED WORKING DURING MANUAL PERITONEAL DIALYSIS EXCHANGES. AN ANTISEPTIC COMPOSED OF N-PROPANOL AND PROPANOL-2 WAS BEING USED TO CLEAN THE TRANSFER SET. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED IN ASSOCIATION WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292445 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H12D16046

    Patients

    Seq Age Sex Outcome Treatment
    1