BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMISSON-CARTLEDGE BIOMEDICAL, LLC

    MDR report key: 9843674 · Received March 17, 2020

    Report

    Report Number
    3006158088-2020-00001
    Event Type
    Malfunction
    Date Received
    March 17, 2020
    Date of Event
    December 31, 2019
    Report Date
    March 3, 2020
    Manufacturer
    SMISSON-CARTLEDGE BIOMEDICAL, LLC
    Product Code
    FRN
    UDI-DI
    00857893006070
    PMA / PMN Number
    K052055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE THERMACOR 1200 INFUSION SYSTEM WAS USED AT (B)(6) ON (B)(6) 2019. THE COMPLAINT WAS RECEIVED AS DURING SET-UP, THE UNIT WAS NOT INFUSING AT RAPID 500. (B)(4) (DISTRIBUTOR) RECEIVED THE COMPLAINT ON DECEMBER 31, 2019 AND REPORTED TO SMISSON-CARTLEDGE BIOMEDICAL, LLC (SCB) ON JANUARY 14, 2020. THE UNIT (B)(4) WAS RECEIVED AND TESTED BY (B)(4) ON JANUARY 20, 2020. NO ISSUE WAS NOTED WITH THE UNIT, AND THE UNIT WAS RETURNED TO THE HOSPITAL. SMISSON-CARTLEDGE BIOMEDICAL, LLC QUESTIONED HOW THE UNIT WAS BEING USED DURING SET-UP AT A RAPID 500 RATE. AFTER REPEATED REQUESTS, AN E-MAIL WAS FORWARDED TO SCB ON MARCH 3, 2020 INDICATING A LEAKING CASSETTE (DNC-1200, LOT 315349) WAS THE CAUSE OF THE UNIT NOT INFUSING. THE INFORMATION RECEIVED INDICATED THE ROLLER PUMP DOOR TUBING MAY HAVE BEEN PINCHED CAUSING A LEAK AT THAT AREA OF THE CASSETTE. BASED ON INFORMATION RECEIVED FROM THE HOSPITAL ON MARCH 16, 2020, THE UNIT WAS SWAPPED OUT WITH ANOTHER THERMACOR 1200 UNIT. THE SURGERY WAS NOT DELAYED DUE TO THE CHANGING OF THE UNIT NOR WAS THERE ANY PATIENT INJURY. RETAINS WERE REVIEWED AND TESTED FOR THIS LOT OF CASSETTES; NO ISSUE WAS NOTED. NO ISSUE HAS BEEN NOTED FOR THIS LOT OF CASSETTES IN THE FIELD. A CORRECTIVE ACTION HAS BEEN ISSUED TO MEDICAL SOLUTIONS, INC (DISTRIBUTOR) TO ADDRESS INCOMPLETE COMPLAINT INFORMATION BEING FORWARDED TO SMISSON-CARTLEDGE BIOMEDICAL (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307840 SMISSON-CARTLEDGE BIOMEDICAL, LLC THERMACOR 1200 INFUSION SYSTEM FRN SMISSON-CARTLEDGE BIOMEDICAL, LLC DNC-1200 315349 00857893006070

    Patients

    Seq Age Sex Outcome Treatment
    1