BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3-SPIKE DISPOSABLE SET

    MDR report key: 14711755 · Received June 16, 2022

    Report

    Report Number
    14711755
    Event Type
    Malfunction
    Date Received
    June 16, 2022
    Date of Event
    May 27, 2022
    Report Date
    May 27, 2022
    Manufacturer
    BELMONT INSTRUMENT CORPORATION
    Product Code
    LGZ
    UDI-DI
    00896128002022
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RN#3 USING BELMONT RAPID INFUSER RI-2 DURING GOLD ALERT TO ADMINISTER BLOOD. BELMONT TUBING WAS SET UP BY RN#1 PER MANUFACTURER'S GUIDELINES. NO EXTENSION TUBING WAS USED. DURING INFUSION, BLOOD BEGAN TO BACK UP AND SPEW OUT OF THE PORT ON TOP OF THE RESERVOIR. RN NEVER ENCOUNTERED THIS ISSUE BEFORE. RN#2 SET UP NEW TUBING AND DURING INFUSION BLOOD BEGAN TO BACK UP AND SPEW OUT THE PORT ON TOP OF THE RESERVOIR. MANUFACTURER RESPONSE FOR WARMER, THERMAL, INFUSION FLUID, 3-SPIKE DISPOSABLE SET (PER SITE REPORTER). SPOKE WITH BELMONT TECHNICAL SUPPORT - SENT COMPANY REPORT FOR COMPLETION. REQUESTED TUBING (X2) INVOLVED WITH ISSUE. TUBING REFRIGERATED IN HOSPITAL LAB UNTIL CAN SEND TO COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254555 3-SPIKE DISPOSABLE SET WARMER, THERMAL, INFUSION FLUID LGZ BELMONT INSTRUMENT CORPORATION 903-00006P 20220315 00896128002022

    Patients

    Seq Age Sex Outcome Treatment
    1 24455 DA Male