BEUDAMED
    FDA Adverse Event Death Summary report: N

    TANDEMHEART ARTERIAL CANNULA

    MDR report key: 3763473 · Received April 7, 2014

    Report

    Report Number
    2531527-2014-00005
    Event Type
    Death
    Date Received
    April 7, 2014
    Date of Event
    March 12, 2014
    Report Date
    March 27, 2014
    Manufacturer
    CARDIACASSIST, INC.
    Product Code
    DWF
    PMA / PMN Number
    K120543
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, (B)(6) REPORTED A CASE WHERE A PATIENT EXPIRED SECONDARY TO THE CANNULA BEING FORCEABLY REMOVED AND EXSANGUINATION. I WANTED TO LET YOU KNOW ONE OF THE PTS ON TANDEM AT (B)(6) DECANNULATED HIMSELF TODAY AND RAPIDLY EXSANGUINATED. AT THIS POINT THERE ARE MORE QUESTIONS THAN ANSWERS, BUT HERE ARE THE FACTS AS I KNOW THEM. THE PT WAS STABLE ON SUPPORT, AWAKE, ALERT, ORIENTED. HE WAS AWARE HE WAS NOT PERMITTED TO BEND HIS LEG OR GET OUT OF BED. HE STOOD UP AND GOT OUT OF BED (SOME SPECULATION TO USE THE BED PAN/ BATHROOM). WHEN THE NURSE WENT INTO THE ROOM HE WAS FACE DOWN ON THE FLOOR WITH NO EVIDENCE OF BLEEDING. THEN HE REPEATEDLY ATTEMPTED TO GET BACK ON HIS FEET. HE WAS A LARGE STRONG MAN. DURING THIS STRUGGLE HE MAY HAVE FORCEFULLY PULLED ON THE SUTURED OUTFLOW CANNULA WITH HIS KNEE OR LEG REMOVING THE SUTURED PROTEK CANNULA. THE IMMEDIATE STEPS TAKEN AT THAT POINT ARE UNKNOWN TO ME. NO OTHER DETAILS WERE CURRENTLY AVAILABLE AS THE STAFF INVOLVED WERE BEING DEBRIEFED WITH INTERNAL HOSPITAL LEADERSHIP AT THE TIME. TH PLACED WITHOUT INCIDENT. ABOVE INITIAL INFORMATION WAS CLARIFIED WITH SITE ON (B)(6) 2014, FURTHER CLARIFICATION FROM SITE REVEALED THE FOLLOWING: BETWEEN 0900 AND 1000 ON (B)(6) 2014 FOR UNKNOWN REASONS, THE PT ROLLED HIMSELF FROM THE SUPINE POSITION IN HIS BED, AND LANDED IN THE PRONE POSITION ON THE FLOOR. THE CONTROLLER (B)(4) WAS POSITIONED ON THE OPPOSITE SIDE OF THE BED. THE PTS NURSE WAS REPORTEDLY IN THE PTS ROOM AT THE DOORWAY AT THIS TIME. SHE IMMEDIATELY CALLED FOR HELP. THE PT WAS MAKING ATTEMPTS TO STAND BY GETTING ON HIS HANDS AND KNEES. BY THE TIME THE STAFF WAS ABLE TO ROLL THE PT ONTO HIS BACK THE ARTERIAL CANNULA HAD BEEN DISLODGED AND THE PT LOST A SIGNIFICANT AMOUNT OF BLOOD. THE IMMEDIATE ACTION TAKEN BY THE STAFF AT THAT TIME REMAINS UNCLEAR. RESUSCITATION EFFORTS WERE UNSUCCESSFUL. PRIOR TO THIS EVENT THE PT WAS AWAKE, ALERT, AND ORIENTED. THE PT ALSO USED THE BED PAN A SHORT TIME PRIOR TO THIS EVENT AND KNEW THE IMPORTANCE OF KEEPING HIS LEG STRAIGHT. HE WAS REPORTEDLY APPROXIMATELY 250-275 LBS AND OVER 6 FEET TALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207041 TANDEMHEART ARTERIAL CANNULA ARTERIAL CANNULA DWF CARDIACASSIST, INC. 5130-1717 AM017457

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death IABP