BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMISSON-CARTLEDGE BIOMEDICAL, LLC

    MDR report key: 10537525 · Received September 15, 2020

    Report

    Report Number
    3006158088-2020-00005
    Event Type
    Malfunction
    Date Received
    September 15, 2020
    Date of Event
    August 26, 2020
    Report Date
    September 15, 2020
    Manufacturer
    SMISSON-CARTLEDGE BIOMEDICAL, LLC
    Product Code
    FRN
    PMA / PMN Number
    052055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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) HOSPITAL, THE STAFF NOTICED THE CASSETTE WAS LEAKING BLOOD FROM THE BOTTOM OF THE CASSETTE. THE HOSPITAL STAFF STATED THAT THE TUBING WAS CLIPPED IN THE ROLLER PUMP DOOR WHICH CAUSED THE LEAK. THE HOSPITAL STAFF POSITIONED THE TUBE INCORRECTLY IN THE ROLLER PUMP WHICH CAUSED THE PINCHED TUBING AND LEAKAGE. THE HOSPITAL CHANGED OVER TO A LEVEL ONE UNIT TO COMPLETE THE SURGERY. NO PATIENT HARM WAS NOTED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002470 SMISSON-CARTLEDGE BIOMEDICAL, LLC THERMACOR 1200 INFUSION SYSTEM FRN SMISSON-CARTLEDGE BIOMEDICAL, LLC PNC-1200

    Patients

    Seq Age Sex Outcome Treatment
    1