BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMISSON-CARTLEDGE BIOMEDICAL, LLC

    MDR report key: 9996503 · Received April 24, 2020

    Report

    Report Number
    3006158088-2020-00004
    Event Type
    Malfunction
    Date Received
    April 24, 2020
    Date of Event
    April 2, 2020
    Report Date
    April 2, 2020
    Manufacturer
    SMISSON-CARTLEDGE BIOMEDICAL, LLC
    Product Code
    FRN
    UDI-DI
    00857893006059
    PMA / PMN Number
    K052055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 USED AT (B)(6) ON (B)(6) 2020. THE HOSPITAL NOTICED THE INITIAL CASSETTE HAD A TWISTED RETURN LINE WHICH CAUSED LIMITED FLOW FOR PRIMING. THE DISPOSABLE CASSETTE WAS CHANGED OUT WITH A SECOND CASSETTE. AFTER THE SURGERY WAS COMPLETED, THE HOSPITAL NOTICE THE SECOND CASSETTE WAS LEAKING FROM THE BOTTOM OF THE CASSETTE. BOTH CASSETTES WERE FROM LOT 313923. THE CASSETTE WITH THE KINKED RETURN LINE WAS RETURNED FOR INVESTIGATION. IT WAS DETERMINED THAT THE YELLOW LUER LOCK SCREW WAS TIGHTENED INCORRECTLY. THE YELLOW LUER LOCK SCREW SHOULD BE USED TO TIGHTEN BUT INSTEAD IT APPEARS THAT THE CLEAR BASE UNDERNEATH WAS TIGHTENED. IT APPEARS THAT THIS INCORRECT TIGHTENING CAUSED RESTRICTED FLOW. THE SECOND CASSETTE, CAUSING THE REPORTABLE EVENT, WAS NOT RETURNED FOR INVESTIGATION; HOWEVER, BASED ON THE PICTURES SUBMITTED BY THE HOSPITAL, IT APPEARS THE ROLLER PUMP DOOR TUBING MAY HAVE BEEN PINCHED CAUSING A LEAK AT THAT AREA OF THE CASSETTE. 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
    458155 SMISSON-CARTLEDGE BIOMEDICAL, LLC THERMACOR 1200 INFUSION SYSTEM FRN SMISSON-CARTLEDGE BIOMEDICAL, LLC PTC-1200 313923 00857893006059

    Patients

    Seq Age Sex Outcome Treatment
    1