BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMISSON-CARTLEDGE BIOMEDICAL, LLC

    MDR report key: 5520499 · Received March 23, 2016

    Report

    Report Number
    3006158088-2016-00004
    Event Type
    Malfunction
    Date Received
    March 23, 2016
    Date of Event
    March 15, 2016
    Report Date
    March 16, 2016
    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

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THE THERMACOR 1200 INFUSION SYSTEM WAS BEING USED AT (B)(6) HOSPITAL ON (B)(6) 2016. THE HOSPITAL STATED THAT DURING THE TRANSFUSION, THE CASSETTE COMPLETELY FILLED WITH BLOOD AND STARTED LEAKING ON THE FLOOR. THE CASSETTE WAS CHANGED OUT, AND THE SURGERY CONTINUED WITH THE THERMACOR 1200 SYSTEM. THE CASSETTE WAS RETURNED FOR INVESTIGATION AND FOUND THAT THE TUBING AT THE ROLLER PUMP DOOR AREA HAD BEEN PINCHED BY THE DOOR CAUSING A CUT IN THE TUBING. NO PATIENT INJURY OR EXTENDED SURGERY TIME WAS NEEDED FOR CHANGING OUT THE CASSETTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175922 SMISSON-CARTLEDGE BIOMEDICAL, LLC THERMACOR 1200 INFUSION SYSTEM FRN SMISSON-CARTLEDGE BIOMEDICAL, LLC PNC-1200 531129079

    Patients

    Seq Age Sex Outcome Treatment
    1