BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFESET

    MDR report key: 12149109 · Received July 12, 2021

    Report

    Report Number
    12149109
    Event Type
    Malfunction
    Date Received
    July 12, 2021
    Date of Event
    January 28, 2021
    Report Date
    July 6, 2021
    Manufacturer
    ICU MEDICAL, INC
    Product Code
    DXN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SITUATION: SAFESET 84¿ ARTERIAL LINE PRESSURE MONITORING TRANSDUCER HAD A BREAK/CRACK THAT DID NOT MAINTAIN PRESSURE THAT ALLOWED BLOOD TO BACK UP INTO TUBING. END USERS WERE UNABLE TO GET A BLOOD PRESSURE ON THE PATIENT AND HAD TO USE A NEW SYSTEM. BACKGROUND: INFOR # (B)(4), DEVICE LOT #4924013. ASSESSMENT: THE DEFECT IS NOT NOTABLE UPON VISUAL INSPECTION (TOO SMALL TO HAVE NOTICED PRIOR TO USE). THIS FAILURE COULD RESULT IN SEVERE HARM TO THE PATIENT IF BLOOD LEAKING WENT UNDETECTED. INITIAL ANALYTICS FROM CORPORATE SUPPLY CHAIN REVEAL THE PRESENCE OF THIS PRODUCT AT (B)(6) HOSPITAL AND (B)(6) HOSPITAL, BUT GIVEN THE POTENTIAL SEVERITY OF IMPACT TO PATIENT SAFETY, MESSAGING SHOULD NOT BE LIMITED TO THOSE SITES IN CASE THERE IS SHARING OF PRODUCT. (B)(6) HOSPITAL DOES NOT HAVE PRODUCT OF AN ALTERNATIVE LOT ON SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1047218 SAFESET SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE DXN ICU MEDICAL, INC 42646-66 4924013

    Patients

    Seq Age Sex Outcome Treatment
    1