BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE INFUSION BAG

    MDR report key: 3966443 · Received June 25, 2014

    Report

    Report Number
    1721504-2014-00130
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 29, 2014
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    KZD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ONE USED DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO EXCEPTION DOCUMENTS WERE FOUND. THE COMPLAINT DATABASE WAS REVIEWED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE BAG WAS PRESSURE TESTED AND FAILED THE PRESSURE TEST. THE COMPLAINT IS CONFIRMED. A SUPPLIER CORRECTIVE ACTION HAS BEEN REQUESTED FROM THE MANUFACTURER.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE PRESSURE INFUSION BAG IS LOOSING PRESSURE. THE PATIENT CAME TO THE CATH LAB WITH AN ACUTE MYOCARDIAL INFARCTION. THE PATIENT WAS SENT TO ICU POST PROCEDURE WITH THE FEMORAL SHEATH SUTURED IN. THE SHEATH WAS CONNECTED TO A PRESSURE BAG WITH HEPARINIZED SALINE TO MAINTAIN PATENCY IN THE SHEATH. THE LOSS OF PRESSURE LED TO CLOT FORMATION IN THE SHEATH. THE SHEATH WAS REMOVED AND REPLACED. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370546 PRESSURE INFUSION BAG INFUSOR, PRESSURE, FOR I.V. BAGS KZD MERIT MEDICAL SYSTEMS, INC. I676226

    Patients

    Seq Age Sex Outcome Treatment
    1 SHEATH