BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMISSON-CARTLEDGE BIOMEDICAL, LLC

    MDR report key: 10568031 · Received September 22, 2020

    Report

    Report Number
    3006158088-2020-00006
    Event Type
    Malfunction
    Date Received
    September 22, 2020
    Date of Event
    August 31, 2020
    Report Date
    September 22, 2020
    Manufacturer
    SMISSON-CARTLEDGE BIOMEDICAL, LLC
    Product Code
    FRN
    UDI-DI
    00857893006066
    PMA / PMN Number
    K052055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SCB COMPLAINT NUMBER - (B)(4).

    Description of Event or Problem · 1

    DURING SURGERY AT (B)(6) MEMORIAL HOSPITAL, THE STAFF NOTICED THE CASSETTE STARTED LEAKING BLOOD AT THE PATIENT LINE CONNECTION TO THE CASSETTE. THE CASSETTE LOT NUMBER WAS LOT 316277. THE HOSPITAL CHANGED OVER TO A LEVEL ONE UNIT TO COMPLETE THE SURGERY. NO PATIENT HARM WAS NOTED BY THE HOSPITAL. THE TUBING WAS RETURNED TO THE DISTRIBUTOR, MEDICAL SOLUTIONS, INC (MSI). MSI FOUND NO ADHESIVE AT THE CASSETTE END OF THE PATIENT LINE WHICH CAUSED THE LEAK AT THE FITTING. RETAINS WERE REVIEWED, AND ADHESIVE WAS PRESENT AT THE CONNECTION. NO OTHER ISSUES HAVE BEEN NOTED FOR THIS LOT. THE DHR WAS REVIEWED; NO ISSUE WAS NOTICED FOR THIS LOT. THE MANUFACTURER HAS BEEN NOTIFIED OF THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034977 SMISSON-CARTLEDGE BIOMEDICAL, LLC THERMACOR 1200 INFUSION SYSTEM FRN SMISSON-CARTLEDGE BIOMEDICAL, LLC PNC-1200 316277 00857893006066

    Patients

    Seq Age Sex Outcome Treatment
    1