BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEMHEART TRANSSEPTAL CANNULA - EF

    MDR report key: 3650176 · Received February 17, 2014

    Report

    Report Number
    2531527-2014-00002
    Event Type
    Injury
    Date Received
    February 17, 2014
    Date of Event
    January 31, 2014
    Report Date
    February 14, 2014
    Manufacturer
    CARDIAC ASSIST, INC.
    Product Code
    DWF
    PMA / PMN Number
    K052570
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, (B)(6) OF THE (B)(6) CLINIC SUPPORT STAFF WAS INFORMED OF A TRANSSEPTAL CANNULA THAT WAS DISLOCATED DUE TO MOVEMENT/MANIPULATION OF THE PT TO CLEAN HER AFTER A LOOSE BOWEL MOVEMENT THAT SOILED HER ALL OVER. THE NURSE AND THE ATTENDING PHYSICIAN WERE PRESENT AT THE TIME OF THE CLEANING. THE DISLODGEMENT OCCURRED WHEN THE PT WAS RETURNED TO A SUPINE POSITION. THE NURSE AND PHYSICIAN NOTICE THE 'COLOR OF THE BLOOD' AND THE PT WAS SENT IMMEDIATELY TO THE CATH LAB. A 72CM TRANSSEPTAL CANNULA WAS PLACED FROM THE LFV. THE PT REMAINED STABLE. PT WAS TRANSITIONED TO HEARTMATE II AND EXPLANTED FROM THE TANDEMHEART ON (B)(6) 2014 WITH NO RESIDUAL NEGATIVE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99809 TANDEMHEART TRANSSEPTAL CANNULA - EF CANNULA, VASCULAR, CARDIOPUL BYPASS DWF CARDIAC ASSIST, INC. 5140-6221

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention