BEUDAMED
    FDA Adverse Event Death Summary report: N

    7" (18 CM) APPX 0.70 ML, EXT SET W/REMV MICROCLAVE® CLEAR, CLAMP, ROTATING LUER

    MDR report key: 16691497 · Received April 6, 2023

    Report

    Report Number
    9617594-2023-00134
    Event Type
    Death
    Date Received
    April 6, 2023
    Date of Event
    February 20, 2023
    Report Date
    March 9, 2023
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00887709047068
    PMA / PMN Number
    K964435
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION. HOWEVER, IT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT OF DISCONNECTION CANNOT BE CONFIRMED. NO PHOTOS, VIDEOS, OR SAMPLES WERE RETURNED FOR EVALUATION. MULTIPLE ATTEMPTS WERE MADE TO RECEIVE THE REPORTED DEVICES OR RELATED SAMPLES OF THE SAME LOT. NO ADDITIONAL SAMPLES OR INFORMATION WERE PROVIDED. THE DEVICE HISTORY REVIEW (DHR) WAS REVIEWED AND NO NON-CONFORMITIES WERE FOUND THAT WOULD HAVE LED TO THE REPORTED COMPLAINT. WITHOUT THE RETURN OF THE USED SAMPLE/SAMPLES, A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED. ADDITIONAL/UPDATED INFORMATION CAN BE FOUND IN D9.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPIRED IN THE CATH LAB DUE TO THE MICROCLAVE® CLEAR TUBING NOT BEING CONNECTED. THE FACILITY INDICATED THAT THEY USE THE PRODUCT AS THEIR PRIMARY TUBING FOR 12517-01, 7" (18 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE¿ CLEAR, PURPLE CLAMP, ROTATING LUER. THE REPORTER ADDED THAT THEY ARE TRYING TO EDUCATE STAFF AND MAKE THEM AWARE THAT THIS CONNECTION IS HARD TO ATTACH AND WILL COME APART IF NOT PLACED PROPERLY. THE PATIENT WAS HAVING A CARDIAC CATHETERIZATION FOR AN ACUTE MYOCARDIAL INFARCTION. DURING THE PROCEDURE, A HEPARIN BOLUS WAS GIVEN. THE CARDIOLOGIST NOTED THROMBI BUILDING UP AROUND THE CARDIAC WIRES WHILE PERFORMING THE PROCEDURE. ACTIVATED CLOTTING TIME (ACT) LEVEL RETURNED AS NORMAL AND SHOULD HAVE READ HIGH AFTER RECEIVING THE HEPARIN. THE INTRAVENOUS (IV) SITE AND CONNECTIONS WERE CHECKED BENEATH THE STERILE DRAPES, AND IT WAS FOUND THAT THE IV TUBING HAD BECOME DISCONNECTED FROM THE IV EXTENSION TUBING. DUE TO THE PATIENT NOT RECEIVING ANY ANTICOAGULANTS, THROMBI FORMED WITHIN THE CARDIAC ARTERY, WHICH RESULTED IN A CARDIAC ARREST. RESUSCITATION EFFORTS WERE NOT SUCCESSFUL, AND THE PATIENT DIED. UPON QUERYING THE STAFF WHO HAVE USED THIS PRODUCT, WE FOUND THAT IT EASILY BECOMES DISCONNECTED FROM THE IV TUBING. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1912684 7" (18 CM) APPX 0.70 ML, EXT SET W/REMV MICROCLAVE® CLEAR, CLAMP, ROTATING LUER STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 12515-01 11376763 00887709047068

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death 12517-01 SMALLBORE PRESSURE INFUSION, ICU MEDICAL.| HEPARIN, UNK MFR.