BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGE CARDIOVASCULAR PERFUSION SET 15" LENGTH, ONE 3"

    MDR report key: 19981443 · Received August 13, 2024

    Report

    Report Number
    MW5158390
    Event Type
    Malfunction
    Date Received
    August 13, 2024
    Report Date
    August 9, 2024
    Manufacturer
    MED MICHIGAN HOLDINGS LLC.
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PERFUSION SETS LEAKING. USED IN CVOR TO DISTRIBUTE CARDIOPLEGIA SOLUTION FROM CPBP TO SVG(S). STAFF USUALLY PULL A SECOND SENT OFF THE SHELF TO HAVE AVAILABLE IN CASE THERE IS A PROBLEM. MULTIPLE SURGICAL CASES - PATIENT INFORMATION NOT AVAILABLE. ANY/ALL OF TUBING SECTIONS UNDER CLAMPS ARE LEAKING. WHEN A LEAK OCCURS, THE CARDIOPLEGIA FLOW IS STOPPED, PERFUSION SET IS CLAMPED OFF AND DISCARDED AND A FRESH, INDIVIDUALLY WRAPPED PERFUSION SET IS OPENED. NO PATIENT INJURIES NOTED. A SAMPLE OF THE EQUIPMENT IN QUESTION HAS BEEN RETURNED TO THE VENDOR. MANUFACTURED 6/23/2020. MEDLINE INDUSTRIES, NORTHFIELD, IL 60093 US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1619388 SURGE CARDIOVASCULAR PERFUSION SET 15" LENGTH, ONE 3" CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF MED MICHIGAN HOLDINGS LLC. PER-1400 03872-0622320

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown