BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENOUS CANNULA

    MDR report key: 11737291 · Received April 27, 2021

    Report

    Report Number
    MW5101019
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Date of Event
    April 21, 2021
    Report Date
    April 23, 2021
    Manufacturer
    SURGE CARDIOVASCULAR / MED MICHIGAN HOLDINGS LLC
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE MINIMALLY INVASIVE AORTIC VALVE REPLACEMENT CASE THAT THERE WAS POOR DRAINAGE OF THE PATIENT'S BLOOD TO THE PERFUSION PUMP FOR THE SURGEON COMPLETE THE PROCEDURE QUICKLY. AT THE END OF THE CASE, THE PERFUSIONIST LOOKED AT THE VENOUS CANNULA AND NOTED THAT IT APPEARED THAT SEVERAL OF THE DRAINAGE HOLES WERE NOT COMPLETELY OPEN FROM THE MANUFACTURING PROCESS. CANNULA WAS SAVED, AND THE LOT NUMBER NOTED. NO APPARENT HARM CAME TO THE PATIENT AND PATIENT WAS TRANSFERRED TO THE ICU FOR RECOVERY. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631648 VENOUS CANNULA CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF SURGE CARDIOVASCULAR / MED MICHIGAN HOLDINGS LLC FEM-V1028 03925-071520

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR