BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3854280 · Received June 6, 2014

    Report

    Report Number
    1416980-2014-18229
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    February 28, 2014
    Report Date
    May 13, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RECEIVED AND EVALUATED. A VISUAL INSPECTION WAS PERFORMED WITH BOTH THE NAKED EYE AND UNDER MICROSCOPE WITH NO ISSUES NOTED. FUNCTIONAL TESTS WERE PERFORMED, INCLUDING CLEAR PASSAGE, CLAMP FUNCTION, AND LEAK TESTING WITH NO ISSUES NOTED. THE REPORTED PROBLEM COULD NOT BE VERIFIED, AND THE CAUSE IS UNDETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MINICAP TRANSFER SET WITH TWIST CLAMP EXPERIENCED A LEAK. THE PATIENT HAS RECEIVED UNKNOWN ANTIBIOTICS AS A PRECAUTIONARY MEASURE. THE EXACT LOCATION OF THE LEAK WAS UNKNOWN. THE REPORTER STATED THAT THEY CUSTOMER USED AN ALCOHOL BASED SOLUTION TO CLEAN THE DISPOSABLE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333109 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1