BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM PERFUSION DUAL LUMEN CANNULA 27F

    MDR report key: 16960947 · Received May 19, 2023

    Report

    Report Number
    3016746283-2023-00004
    Event Type
    Malfunction
    Date Received
    May 19, 2023
    Date of Event
    May 12, 2023
    Report Date
    June 16, 2023
    Manufacturer
    QURA S.R.L.
    Product Code
    DWF
    UDI-DI
    08051160300808
    PMA / PMN Number
    221353
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RELATED TO THE EVENT WILL BE AVAILABLE AFTER THE INVESTIGATION OF THE RETURNED DEVICE, WHICH COULD BE ADDRESSED IN A FOLLOW-UP REPORT. PATIENT ADEQUATELY SUPPORTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RELATED TO THE EVENT IS ATTACHED.

    Description of Event or Problem · 0

    RECEIVED A CALL THAT THEY EXPERIENCE A FRACTURE TO A 27FR DUAL LUMEN CANNULA. CANNULA HAD BEEN IN FOR 7 DAYS. PATIENT ALSO HAS A HEARTMATE 3 LVAD. WITH FRACTURE OF THE CANNULA, THE SYSTEM ENTRAINED AIR. CANNULA WAS PULLED AND PATIENT PLACED ON DOBUTAMINE FOR RIGHT SIDE SUPPORT. PATIENT ADEQUATELY SUPPORTED.

    Description of Event or Problem · 0

    RECEIVED A CALL THAT THEY EXPERIENCE A FRACTURE TO A 27FR DUAL LUMEN CANNULA. CANNULA HAD BEEN IN FOR 7 DAYS. PATIENT ALSO HAS A HEARTMATE 3 LVAD. WITH FRACTURE OF THE CANNULA, THE SYSTEM ENTRAINED AIR. CANNULA WAS PULLED AND PATIENT PLACED ON DOBUTAMINE FOR RIGHT SIDE SUPPORT. PATIENT ADEQUATELY SUPPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463942 QUANTUM PERFUSION DUAL LUMEN CANNULA 27F DUAL LUMEN CANNULAE DWF QURA S.R.L. DL27F-VO E003012 08051160300808

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention HEARTMATE 3 LVAD| HEARTMATE 3 LVAD