BEUDAMED
    FDA Adverse Event Death Summary report: N

    KIT, 2 EXT SET, STANDARD/SMALLBORE, 4-GANG STOPCOCK, 11 CLAVE¿ CLEAR, 3 STOPCOCK

    MDR report key: 13876467 · Received March 24, 2022

    Report

    Report Number
    9617594-2022-00062
    Event Type
    Death
    Date Received
    March 24, 2022
    Date of Event
    March 4, 2022
    Report Date
    March 7, 2022
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    PMA / PMN Number
    K964435
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 0

    NO PRODUCT SAMPLES, VIDEOS, OR PHOTOGRAPHS WERE PROVIDED FOR INVESTIGATION. AFTER MULTIPLE ATTEMPTS TO TRY AND GET SISTER SAMPLES FOR INVESTIGATION AS REQUIRED BY A LEVEL 3 INVESTIGATION, THE ATTEMPTS WERE UNSUCCESSFUL. NO DEVICE HISTORY REVIEW (DHR), LOT REVIEW WAS CONDUCTED BECAUSE NO LOT NUMBER(S) WAS/WERE IDENTIFIED. A PROBABLE CAUSE CANNOT BE IDENTIFIED BASED ON THE INFORMATION THAT HAS BEEN PROVIDED.

    Additional Manufacturer Narrative · 0

    ICU MED RECEIVED AN EMAIL FROM THE CUSTOMER ON 4/26/2023 NOTIFYING US THAT THE EVENT ON THIS RECORD IS A DUPLICATE OF CN-199124 / 9617594-2023-00106. BOTH CN-199124 / MDR 9617594-2023-00106 AND CN-150754 / MDR 9617594-2022-00062 IS THE SAME INCIDENT INVOLVING THE SAME PATIENT. THIS RECORD WILL BE CLOSED AND ALL INFORMATION INCLUDING THE INVESTIGATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT UNDER CN-199124 / 9617594-2023-00106.

    Description of Event or Problem · 0

    THE EVENT TOOK PLACE ON (B)(6) 2022 IN THE INTENSIVE CARE UNIT (ICU) AND INVOLVED AN UNSPECIFIED DISPOSABLE DEVICE. THE ICU MEDICAL LINE BROKE FOLLOWING A HERNIA (BULGE/PROTRUSION) THAT OCCURRED IN THE TUBING DURING THE INJECTION OF A HIGH-KINETIC CONTRAST PRODUCT ON THE PROXIMAL STOPCOCK. THERE WERE NO PHYSICAL DEFECTS NOTED ON THE DEVICE BEFORE THE INCIDENT. DUE TO THE INCIDENT, THERAPY WAS NOT COMPLETED, AND THE SCAN COULD NOT BE PERFORMED. IT WAS NECESSARY TO RE INSERT A PERIPHERAL VENOUS LINE TO CARRY OUT THE SCAN. THE PATIENT WAS SEDATED, INTUBATED, AND VENTILATED DURING AND AFTER THE EVENT . DETERIORATION OF THE PATIENT EVENTUALLY LEAD TO DEATH. HOWEVER, IT WAS STATED BY THE ICU NURSE THAT ¿THE PATIENT PRESUMABLY SHOWED NO CONSEQUENCES OF THE INCIDENT AND DIED OF ANOTHER CAUSE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863303 KIT, 2 EXT SET, STANDARD/SMALLBORE, 4-GANG STOPCOCK, 11 CLAVE¿ CLEAR, 3 STOPCOCK STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death HIGH KINETIC CONTRAST, MFR UNK