BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1 FLUID WARMER IV SET

    MDR report key: 17607644 · Received August 23, 2023

    Report

    Report Number
    3012307300-2023-08326
    Event Type
    Malfunction
    Date Received
    August 23, 2023
    Date of Event
    June 7, 2023
    Report Date
    October 27, 2023
    Manufacturer
    ST PAUL
    Product Code
    KZL
    UDI-DI
    20695085410017
    PMA / PMN Number
    BK860023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: ONE (1) PHOTO WAS PROVIDED BY THE CUSTOMER. (8) PHOTOS AND ONE (1) VIDEO WERE PROVIDED BY THE DECONTAMINATION CENTER WHICH WAS USED TO CONDUCT THE DEVICE ANALYSIS SINCE THE PHYSICAL UNIT, BY THE TIME THIS INVESTIGATION IS BEING DOCUMENTED, WAS NOT ABLE TO BE FULLY DECONTAMINATED AND HAS NOT BEEN RECEIVED AT THE MANUFACTURING SITE. THE PHOTO PROVIDED BY THE CUSTOMER SHOWS A LABEL FOR A PRODUCT OF PART NUMBER DI-100 AND LOT NUMBER 4170271; THE DEVICE IS NOT OBSERVED ON THIS PHOTO. THE EIGHT PHOTOS SHOW A NORMOTHERMIC IV ADMINISTRATION SET OF PART NUMBER DI-100 DISASSEMBLED INTO ITS MULTIPLE COMPONENTS. THE DEVICE IS OBSERVED TO HAVE DRY BLOOD IN MULTIPLE TUBES, ESPECIALLY ON THE EDGES OF CONNECTING PARTS. THE VIDEO SHOWS THE PROXIMAL END ASSEMBLY FROM THE DRIP CHAMBERS TO THE WARMING TUBE SUBMERGED IN A WATER TUB. PRESSURIZED AIR IS INTRODUCED FROM THE DISTAL END WHILE THE SPIKES ARE BLOCKED BY HAND. AS THE AIR IS PUSHED THROUGH THE DEVICE AIR BUBBLES ARE OBSERVED ON THE 3-Y CONNECTOR FROM THE JOINT BETWEEN THE DRIP CHAMBER TAIL AND THE 3-Y CONNECTOR. THE REPORTED FAILURE MODE, LEAK, IS CONFIRMED. ROOT CAUSE COULD NOT BE ESTABLISHED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWS THERE WERE NO OBSERVATIONS OR NONCONFORMITIES RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCTS. NO CORRECTIVE ACTIONS ARE REQUIRED BECAUSE THE MITIGATIONS IN PLACE WERE REVISED AND ARE BEING EXECUTED AS IS DETERMINED BY PROCEDURE. THIS FAILURE WILL CONTINUE TO BE MONITORED TO DETERMINE IF NEW ACTIONS NEED TO BE TAKEN.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS LEAKAGE AT THE TUBING PART OF THE DEVICE. THERE HAS BEEN NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1495916 LEVEL 1 FLUID WARMER IV SET DEVICE, WARMING, BLOOD AND PLASMA KZL ST PAUL 4170271 20695085410017

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown