BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1 FLUID WARMER

    MDR report key: 12018445 · Received June 17, 2021

    Report

    Report Number
    3012307300-2021-06178
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    May 1, 2021
    Report Date
    May 1, 2023
    Manufacturer
    ST PAUL
    Product Code
    KZL
    UDI-DI
    20695085406010
    PMA / PMN Number
    BK860023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS#617147. NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THIS DEVICE HISTORY RECORD REVIEW. ONE UNIT WAS RECEIVED FOR EVALUATION; THE RETURNED UNIT WAS RECEIVED IN DECONTAMINATED CONDITION AND INSIDE OF A PLASTIC BAG WHICH IS NOT THE ORIGINAL PACKAGE. VISUAL AND FUNCTIONAL TESTING WAS PERFORMED. THE COMPLAINANT RETURNED UNIT WAS VISUALLY INSPECTED AT 12? TO 16? UNDER NORMAL CONDITIONS OF ILLUMINATION. NO DEFECTS WERE OBSERVED. THE UNIT WAS TESTED FOR OCCLUSION BY INTRODUCING COLORED WATER IN THE PRODUCT AND NO OCCLUSION WAS OBSERVED, AND THE WATER PASSED THROUGH THE UNIT. THE COMPLAINT WAS NOT CONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE WAS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    CUSTOMER FACILITY PHONE NUMBER: (B)(6).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL FLUID WARMER WAS ATTEMPTING TO BE PRIMED BUT IT COULD NOT BE DONE SUCCESSFULLY. THERE WAS NO PATIENT INJURY. THE CIRCULATING WATER DOES NOT FLOW BECAUSE THE THREE LUMEN TUBES ARE INSTALLED WITH A 90 DEGREE OFFSET FROM THE MANIFOLD. THERE WERE NO REPORTED ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916638 LEVEL 1 FLUID WARMER DEVICE, WARMING. BLOOD AND PLASMA KZL ST PAUL DI-60HL 4080964 20695085406010

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown