BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3972456 · Received August 1, 2014

    Report

    Report Number
    1416980-2014-24948
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 9, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A RETURNED SAMPLE WAS EVALUATED. A VISUAL INSPECTION WAS PERFORMED WITH THE NAKED EYE AND A MICROSCOPE; BROKEN OCCLUDER FEET WERE NOTED. A LEAK TEST AND CLEAR PASSAGE TEST WERE PERFORMED WITH NO ISSUES NOTED. A CLAMP FUNCTION TEST WAS PERFORMED WITH A LEAK NOTED DUE TO THE BROKEN OCCLUDER FEET. THE REPORTED PROBLEM WAS IDENTIFIED DURING EVALUATION BUT THE CAUSE COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND THE EVALUATION IS IN PROGRESS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MINICAP EXTEND LIFE PD TRANSFER SET LEAKED WHILE THE CLAMP WAS CLOSED. THIS OCCURRED DURING PATIENT USE. THE PATIENT REPLACED THE TRANSFER SET AS A RESULT OF THIS EVENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449839 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1