BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3903215 · Received June 30, 2014

    Report

    Report Number
    1416980-2014-20940
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE DEVICE HAS BEEN RECEIVED BY BAXTER, BUT THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). A USED PATIENT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL INSPECTIONS WERE PERFORMED. LEAK TESTING, CLEAR PASSAGE TESTING, AND CLAMP FUNCTION TESTING WERE PERFORMED. SAMPLE ANALYSIS DID NOT VERIFY THE REPORTED ISSUE AND THE SAMPLE ANALYSIS DETERMINED THE PRODUCT MET PRODUCT SPECIFICATIONS. UPON CONCLUSION OF THE INVESTIGATION, THE CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S TRANSFER SET LEAKED AT THE TWIST CLAMP WHEN IT WAS OPENED, DURING USE. THIS WAS FOUND WHEN THE PATIENT HAD COME IN FOR A PERITONEAL DIALYSIS (PD) CATHETER FLUSH. THE PATIENT WAS GIVEN ANTIBIOTICS AS A PRECAUTION. THE REPORTER STATED THAT THERE WAS VISUALLY NO EVIDENCE OF AN ISSUE UNTIL THE TRANSFER SET WAS BEING USED. IT WAS LEAKING AT THE TWIST CLAMP, WHERE THE LIGHT BLUE PORTION (MAINBODY) MEETS WITH THE WHITE PORTION (TWIST SLEEVE). THERE WAS NO LEAK WHEN THE TRANSFER SET WAS CLOSED, JUST WHEN IT WAS OPENED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380048 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 PD CATHETER