BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUANTUM

    MDR report key: 14266989 · Received May 2, 2022

    Report

    Report Number
    MW5109472
    Event Type
    Injury
    Date Received
    May 2, 2022
    Date of Event
    April 11, 2022
    Report Date
    April 28, 2022
    Manufacturer
    QUANTUM PERFUSION / QURA S.R.L.
    Product Code
    DWF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NO INFORMATION
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    CANNULA BECAME DETACHED AT A BONDED SITE CAUSING AIR ENTRAINMENT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1218645 QUANTUM CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF QUANTUM PERFUSION / QURA S.R.L. 221219 D002352

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male Required Intervention