BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2895455 · Received January 3, 2013

    Report

    Report Number
    1416980-2013-00185
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 14, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER. THE SAMPLE WAS NOT RETURNED TO BAXTER, THEREFORE NO EVALUATION COULD BE PERFORMED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THIS COMPLAINT FOR A LEAK WAS NOT CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER (B)(4) REGARDING A LEAK FROM A MINICAP TRANSFER SET. THE CUSTOMER STATED THAT THE TRANSFER SET WAS LEAKING EVEN THOUGH THE CLAMP WAS CLOSED. THE PATIENT GOT THE TRANSFER SET ON (B)(6) 2012 BUT HAD TO HAVE IT REPLACED ON (B)(6) 2012 DUE TO THE LEAKAGE. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1959 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H12B20018

    Patients

    Seq Age Sex Outcome Treatment
    1