BEUDAMED
    FDA Adverse Event Death Summary report: N

    TERUMO SOFT FLOW CANNULA

    MDR report key: 1700207 · Received May 25, 2010

    Report

    Report Number
    1828100-2010-00508
    Event Type
    Death
    Date Received
    May 25, 2010
    Date of Event
    October 4, 2009
    Report Date
    May 25, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWF
    PMA / PMN Number
    K934127
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IN PROGRESS, BUT NOT YET CONCLUDED. THE CANNULA WAS BEING USED OFF LABEL AS AN INFLOW CANNULA FOR POST CARDIOTOMY VENTRICULAR SUPPORT. THE DEVICE INSTRUCTIONS FOR USE INDICATE: "..FOR USE IN PERFUSION OF THE ASCENDING AORTA DURING CARDIOPULMONARY BYPASS SURGERY. THESE DEVICES ARE INDICATED FOR UP TO 6 HOURS OF USE." THE COMPLAINT DESCRIBED THAT THE CANNULA WAS IN PLACE FOR TWO DAYS, CONTRARY TO ITS DOCUMENTED INTENDED USE. IN ADDITION, MOVING A PT WHO IS ON POST PERICARDIOTOMY SUPPORT IS A VERY DANGEROUS SITUATION AS THE CANNULA IS ATTACHED TO TUBING THAT CAN BE EASILY SNAGGED OR MALPOSITIONED ALLOWING STRESS TO BE PLACED DIRECTLY ON THE AORTIC CANNULATION SITE AND THE REMOVAL OF THE CANNULA FROM THE AORTA. THE CANNULA ITSELF WOULD PLAY NO CONTRIBUTORY ROLE IN THIS ADVERSE OUTCOME. FROM THE DESCRIPTION PROVIDED, IT APPEARS THAT NORMAL PLACEMENT AND SECURING TECHNIQUES WERE OBSERVED. THE CANNULA WAS PULLED OUT OF THE AORTA, THERE WAS NO FAILURE NOTED OF THE CANNULA IN THE MAUDE REPORT.

    Description of Event or Problem · 1

    TERUMO (B) (4) BECAME AWARE OF THIS EVENT (B) (6) 2010, DURING A REVIEW OF THE MAUDE DATABASE: "PT ADMITTED IN 2009, FOR NON-ST ELEVATION MI. CARDIAC CATH SHOWED TRIPLE VESSEL DISEASE WITH STENTING OF LEFT ANTERIOR DESCENDING AND INSERTION OF INTRA-AORTIC BALLOON PUMP. PT REMAINED IN CARDIOGENIC SHOCK DESPITE INOTROPIC SUPPORT AND UNDERWENT CARDIOPULMONARY BYPASS AND INSERTION OF BIVENTRICULAR ASSIST DEVICE THE SAME DAY. AORTIC CANNULA SECURED WITH 2 PLEDGED PURSE STRING SUTURES, TOURNIQUETS AND TIES. TWO DAYS LATER, WHILE TURNING PT, THE PT HEMORRHAGED AND EXPIRED. ON OPENING THE CHEST, THE AORTIC CANNULA WAS FOUND TO HAVE SLIPPED OUT OF THE AORTA." NOTE: THE CUSTOMER DID NOT NOTIFY THE MANUFACTURER REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO SOFT FLOW CANNULA AORTIC CANNULA DWF TERUMO CARDIOVASCULAR SYSTEMS CORP. 4951 0559951

    Patients

    Seq Age Sex Outcome Treatment
    1 Death