BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM MEDICAL DUAL LUMEN CANNULA

    MDR report key: 16947574 · Received May 16, 2023

    Report

    Report Number
    MW5117591
    Event Type
    Injury
    Date Received
    May 16, 2023
    Date of Event
    May 12, 2023
    Report Date
    May 12, 2023
    Manufacturer
    SPECTRUM MEDICAL/QURA S.R.L.
    Product Code
    DWF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE SPECTRUM CANNULA OF A RIGHT VENTRICULAR ASSIST DEVICE (RVAD) CRACKED AT THE INSERTION SITE WHILE IN USE ON THE PATIENT. THIS LED TO AIR ENTRAPMENT. THE RVAD DETECTED THE AIR AND SHUT OFF APPROPRIATELY. THE RVAD AND CANNULA WERE REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1907665 SPECTRUM MEDICAL DUAL LUMEN CANNULA CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF SPECTRUM MEDICAL/QURA S.R.L. DL27F-V0

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Life Threatening| R