BEUDAMED
    FDA Adverse Event Death Summary report: N

    CENTRIMAG 24F RETURN CANNULA

    MDR report key: 3848849 · Received May 29, 2014

    Report

    Report Number
    2916596-2014-00760
    Event Type
    Death
    Date Received
    May 29, 2014
    Date of Event
    April 26, 2014
    Report Date
    April 28, 2014
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE CANNULA FOR ANALYSIS. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS SUPPORTED WITH AN ACUTE BLOOD PUMP SYSTEM. IT WAS REPORTED THAT APPROX 5 DAYS POST IMPLANT AND DURING THE PT'S ROUTINE CARE (BATHING AND POSITION CHANGE), THE RETURN FLOW CANNULA BECAME DECANNULATED FROM THE AORTA. THE PT IMMEDIATELY UNDERWENT AN EMERGENCY THORACOTOMY IN THE ICU. REPLACEMENT OF THE CANNULA WAS NOT SUCCESSFUL DUE TO SEVERE HYPOVOLEMIA. THE PT WAS SUCCESSFULLY PLACED ON CARDIOPULMONARY BYPASS WITHIN 20 MINUTES; HOWEVER, IT WAS LATER DISCONTINUED DUE TO THE NEUROLOGICAL IMPACT EXPERIENCED BY THE PT (WIDE, NON-REACTIVE PUPILS AFTER 20-30 MINUTES). THE PT EXPIRED AND THE REPORTED CAUSE OF DEATH WAS INTERNAL EXSANGUINATION. IT WAS REPORTED THAT THE RETURN FLOW CANNULA HAD BEEN PLACED APPROX 4CM BELOW THE FIRST BRANCH OFF THE AORTA AND HAD BEEN INSERTED TO A DEPTH OF APPROX 2CM. TWO STABILIZATION RINGS HAD BEEN SECURED TO THE CANNULA WITH A HEAVY TIE RUNNING AROUND THE CANNULA AND PLASTIC TUBE "SNUGGERS" AND THEN THROUGH THE SMALLEST SUTURE STABILIZATION RING. ADDITIONALLY, THE CANNULA WAS FIXED WITH SUTURE TO THE PERICARDIUM AT THE LEVEL OF THE DIAPHRAGM, TO THE SKIN AT THE EXIT SITE, AND TO THE SKIN A SECOND TIME 5CM DISTAL TO THE EXIT SITE. THESE SUTURES WERE PLACED TO ALLOW SOME SLACK IN THE CANNULA INSIDE THE CHEST TO AVOID PULLING ON THE PURSE STRING SUTURES IN THE EVENT OF EXTERNAL TENSION ON THE CANNULA OR PUMP TUBING. DURING THE EMERGENCY THORACOTOMY, THE SURGEON NOTED THAT THE SMALLER STABILIZATION RING HAD MIGRATED TOWARDS THE TIP OF THE RETURN CANNULA AND THE CANNULA HAD EXITED THE AORTA. THE PURSE STRINGS AND THE FIXATION POINT SUTURES WERE SOLIDLY INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316836 CENTRIMAG 24F RETURN CANNULA DSQ: CENTRIMAG CANNULA DSQ THORATEC SWITZERLAND GMBH 201-50056

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death