BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMISSON-CARTLEDGE BIOMEDICAL, LLC

    MDR report key: 6987208 · Received October 30, 2017

    Report

    Report Number
    3006158088-2017-00001
    Event Type
    Malfunction
    Date Received
    October 30, 2017
    Date of Event
    October 11, 2017
    Report Date
    October 20, 2017
    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
    HEALTH 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) 2017. THE HOSPITAL STATED THAT DURING THE SURGERY, THE CASSETTE STARTED LEAKING FLUID ONTO THE FLOOR. THE CASSETTE WAS CHANGED OUT, AND THE SURGERY CONTINUED WITH THE THERMACOR 1200 SYSTEM. THE CASSETTE WAS NOT RETURNED FOR INVESTIGATION. HOWEVER, THE BIOMED THOUGHT 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
    766354 SMISSON-CARTLEDGE BIOMEDICAL, LLC THERMACOR 1200 INFUSION SYSTEM FRN SMISSON-CARTLEDGE BIOMEDICAL, LLC PNC-1200 531129062

    Patients

    Seq Age Sex Outcome Treatment
    1