BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTRAN PLUS

    MDR report key: 9699911 · Received February 12, 2020

    Report

    Report Number
    9699911
    Event Type
    Malfunction
    Date Received
    February 12, 2020
    Date of Event
    October 28, 2019
    Report Date
    October 31, 2019
    Manufacturer
    UTAH MEDICAL PRODUCTS, INC.
    Product Code
    CBT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INFANT WITH ARTERIAL BLOOD TRANSDUCER IN PLACE, BUT IT WAS NOT READING A WAVEFORM WELL AND HAD TROUBLE DRAWING FROM IT. FOUND TO CLOT OFF DURING THE NIGHT AND THE LINE WAS REMOVED. THE LOT NUMBERS THAT WERE FOUND TO NOT WORK WELL WERE 1190543 AND 1190269, BUT ON THIS NIGHT THE NEWEST LOT THAT WAS SHIPPED WAS TRIED - 1191159. THE NURSES FOUND THAT THE OLDER LOT NUMBERS: 1182159, 1181934 AND 1183165 HAD ALL WORKED WELL. BUT THE NUMBER OF THESE PRODUCTS WERE RUNNING LOW, SO THE NEW LOT WAS TRIED. THE NURSES REPORTED THAT IT WAS "BOUNCING" IN AND OUT OF GOOD WAVE FORM. AFTER THE TUBING HAD BEEN CHANGED, 5 HOURS LATER THE LINE HAD CLOTTED AND HAD TO BE PULLED. THERE WAS NO KNOWN INJURY TO ANY PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161914 DELTRAN PLUS ARTERIAL BLOOD SAMPLING KIT CBT UTAH MEDICAL PRODUCTS, INC. 1191159

    Patients

    Seq Age Sex Outcome Treatment
    1 8 DA