BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3160023 · Received June 10, 2013

    Report

    Report Number
    1416980-2013-14872
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Report Date
    May 22, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER. THE INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION BUT THE EVALUATION HAS NOT YET BEEN COMPLETED. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE USED DEVICE WAS RECEIVED WITH A CAP ON THE DARK BLUE CONNECTOR. VISUAL INSPECTION WAS PERFORMED WITH NO ISSUES NOTED. LEAK TEST, CLEAR PASSAGE TEST AND CLAMP FUNCTION TEST WAS PERFORMED WITH NO ISSUES NOTED. FUNCTIONALLY HAND TIGHTENED A LAB TITANIUM ADAPTER TO SET WITH DIFFICULTY NOTED. THE SAMPLE EVALUATION CONFIRMED THE REPORTED PROBLEM. A CAPA (CORRECTIVE ACTION PREVENTATIVE ACTION) WAS OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED TRANSFER SET FOR A REPORT OF A LEAK, A CONNECTION ISSUE WAS FOUND WITH THE TRANSFER SET. THERE WAS PATIENT INVOLVEMENT WITH THE DEVICE AT THE TIME OF THE ORIGINAL REPORT BUT 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
    260414 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 TITANIUM ADAPTER