BEUDAMED
    FDA Adverse Event Summary report: N

    TERUMO SANS CARDIOPLEGIA SET

    MDR report key: 2628975 · Received June 13, 2012

    Report

    Report Number
    2628975
    Date Received
    June 13, 2012
    Date of Event
    May 31, 2012
    Report Date
    June 11, 2012
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS
    Product Code
    DWF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    (B)(6) PT WITH A HEART DEFECT AND VALVULAR HEART DISEASE THAT INCLUDED A ROSS PROCEDURE WITH AORTIC VALVE REPLACEMENT IN 2001. FOLLOWING A HEART CATHETERIZATION, THE PT PRESENTED TO THE HOSPITAL FOR A REDO-STERNOTOMY WITH PULMONARY VALVE REPLACEMENT AND REPAIR OF ASCENDING THORACIC AORTIC ANEURYSM. DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO WEAN THE PT OFF OF THE CARDIOPULMONARY BYPASS MACHINE. ONCE THE PT REACHED A POINT OF 1.5 TO 2.0 L OF FLOW, THE PT WOULD BEGIN TO DETERIORATE. THERE WAS AN INABILITY TO INCREASE THE FLOW. THE RIGHT VENTRICLE FUNCTION DETERIORATED ALL ATTEMPTS TO WEAN THE PT OFF BYPASS FAILED AND THE PT EXPIRED. IT IS UNKNOWN AT THIS TIME IF THERE WAS A PRODUCT PROBLEM AND IF ANY PRODUCT PROBLEM CONTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO SANS CARDIOPLEGIA SET CARDIOPLEGIA DWF TERUMO CARDIOVASCULAR SYSTEMS NA PC13A

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Death