BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMISSON-CARTLEDGE BIOMEDICAL, LLC

    MDR report key: 12321517 · Received August 13, 2021

    Report

    Report Number
    3006158088-2021-00001
    Event Type
    Malfunction
    Date Received
    August 13, 2021
    Date of Event
    July 15, 2021
    Report Date
    August 13, 2021
    Manufacturer
    SMISSON-CARTLEDGE BIOMEDICAL, LLC
    Product Code
    FRN
    PMA / PMN Number
    K052055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE THERMACOR 1200 INFUSION SYSTEM WAS USED AT (B)(6) HOSPITAL. AFTER THE SURGERY CASE BEGAN, THE HOSPITAL STATED THE RIGID FLUID RESERVOIR LINE WAS NOT FULLY ENGAGED INTO THE CASSETTE LINE, AND THE LINES DISCONNECTED. DUE TO THE OPERATOR ERROR OF NOT CONNECTING THE LINES PROPERLY, THE RETURN LINE YELLOW CONNECTOR WAS NOT COMPLETELY TIGHTENED ON THE RESERVOIR LINE, THIS CAUSED THE LINES TO SEPARATE AND BLOOD TO SPILL ONTO THE UNIT. THE THERMACOR 1200 INFUSION PUMP WAS RETURNED FOR CLEANING AND FINAL INSPECTION TESTING. THE UNIT WAS RECEIVED ON AUGUST 3, 2021. THE UNIT IS CURRENTLY UNDERGOING CLEANING AND TESTING AT MSI. THE PNC-1200, LOT 324164, WAS ALSO RETURNED. THE CASSETTE WAS REVIEWED AND NO ISSUE WAS NOTED WITH THE CASSETTE. BASED ON THE HOSPITAL FEEDBACK AND THE REVIEW OF THE CASSETTE, IT WAS CONFIRMED THAT THIS WAS AN USER ERROR. THE SURGERY WAS DELAYED SLIGHTLY DUE TO THE CHANGING OF THE CASSETTES; HOWEVER, NO PATIENT INJURY WAS NOTED. NO ISSUE HAS BEEN NOTED FOR THIS LOT OF CASSETTES IN THE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1215968 SMISSON-CARTLEDGE BIOMEDICAL, LLC THERMACOR 1200 INFUSION SYSTEM FRN SMISSON-CARTLEDGE BIOMEDICAL, LLC PNC-1200 324164

    Patients

    Seq Age Sex Outcome Treatment
    1