BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 3223044 · Received July 12, 2013

    Report

    Report Number
    1416980-2013-18139
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE WAS NOT RECEIVED BUT 56 UNUSED COMPANION DEVICES WERE RECEIVED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND NO ISSUES WERE NOTED. THE DEVICES WERE THREADED ONTO A LUER CONNECTOR AND EACH DEVICE FIT TIGHTLY AND WAS NOT LOOSE. THE DEVICES WERE UNDERWATER PRESSURE TESTED WITH NO LEAKS DETECTED. THE REPORTED ISSUE COULD NOT BE DUPLICATED OR CONFIRMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR POTENTIALLY ASSOCIATED LOT NUMBER GD894022 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MINICAP WITH POVIDONE-IODINE SOLUTION HAD DISCONNECTED FROM THE TRANSFER SET DURING USE. WHEN THE CUSTOMER WAS TRYING TO TWIST THE MINICAP ONTO THE TRANSFER SET, IT ONLY TOOK ONE TURN TO ATTACH THE MINICAP WHEN IT NORMALLY TAKES MORE THAN THAT. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324463 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND GD894022

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR MINICAP TRANSFER SET