BEUDAMED
    FDA Adverse Event Death Summary report: N

    CANNULA & CATHETER

    MDR report key: 11789016 · Received May 7, 2021

    Report

    Report Number
    8010762-2021-00291
    Event Type
    Death
    Date Received
    May 7, 2021
    Date of Event
    April 29, 2021
    Report Date
    July 9, 2021
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DWF
    PMA / PMN Number
    K102532
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT JUGULAR CANNULA TORN OFF. THE BLOOD EXPLODED ON CUSTOMER GAS BLENDER (SECHRIST) AND ROTAFLOW (MAQUET) AND ACCORDING TO THE HEALTHCARE EXECUTIVE, THE CANNULA WAS EJECTED FROM THE EQUIPMENT. THE PATIENT DIED. THE PRODUCT IS NOT AVAILABLE FOR INVESTIGATION AS IT WAS DISCARDED BY THE CUSTOMER. ON 2021-06-24, THE USER FACILITY CONFIRMS THAT THE ACCIDENTAL DECANNULATION OF THE ECMO RIGHT JUGULAR REINJECTION CANNULA IS DIRECTLY RELATED TO A RUPTURE OF THE CANNULA FIXATION SUTURE. THE DEATH WAS NOT ATTRIBUTED TO THE DEVICE. THE MEDICAL REVIEW SHOWS, THE DECANNULATION OF THE PATIENT WAS NOT THE RESULT OF THE PRODUCT. MOREOVER, FROM THE DETAILS PROVIDED IN THE CONTEXT OF THE COMPLAINT, IT IS NOT KNOWN WHETHER THE DECANNULATION EVENT, AN INCREASE IN CLINICAL COMPLEXITY, OR AN UNDIAGNOSED COMORBIDITY, WAS/WERE THE ROOT CAUSE(S) OF THE PATIENT¿S EXPIRATION. THE HLS CANNULA INSTRUCTIONS FOR USE STRESSES THE IMPORTANCE OF SECURELY ANCHORING THE CANNULA TO THE VESSEL OR SURROUNDING TISSUE TO PREVENT THE ACCIDENTAL DISLOCATION DURING THE EXTRACORPOREAL CIRCULATION. IF, AS THE CUSTOMER DESCRIBED IN THIS COMPLAINT, THE CANNULA IS NOT PROPERLY SECURED WITH SUTURES, THEN DISLOCATION OF THE CANNULA MAY OCCUR WITH THE POSSIBLE RESULT OF DECANNULATION. THE ROOT CAUSE OF THE DECANNULATION EVENT DOES NOT APPEAR TO BE RELATED TO PRODUCT MALFUNCTION OR A DECREASE IN PRODUCT PERFORMANCE, BUT TO THE LOSS OF CANNULA SECUREMENT TO THE SURROUNDING TISSUES. BASED ON THESE INFORMATION, THE CAUSE OF THE EVENT COULD NOT BE ATTRIBUTED TO THE DEVICE. THE CAUSE COULD BE CANNULA FIXATION SUTURE AS REPORTED BY CUSTOMER. THE OCCURRENCE RATE WAS CALCULATED FOR THE REPORTED FAILURE AND PRODUCT AND IT WAS DETERMINED THAT THIS IS NOT A SYSTEMIC ISSUE. THEREFORE, NO REMEDIAL ACTION IS REQUIRED. THE OCCURRENCE RATE RELATED TO THE REPORTED ISSUE IS CURRENTLY BEING MONITORED AS PART OF MAQUET CARDIOPULMONARY¿S TRENDING PROGRAM AND ADDITIONAL INVESTIGATIONS OR CORRECTIONS WILL BE IMPLEMENTED IN CASE OF ADVERSE TRENDING. H3 OTHER TEXT: DISCARDED BY CUSTOMER.

    Description of Event or Problem · 0

    COMPLAINT#: (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL ONGOING. PRODUCT AND FURTHER INFORMATION ABOUT THE EVENT HAVE BEEN REQUESTED BUT NOT RECEIVED YET. A FOLLOW-UP REPORT WILL BE SENT WHEN FURTHER INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT JUGULAR CANNULA TORN OFF. THE BLOOD EXPLODED ON CUSTOMER GAS BLENDER (SECHRIST) AND ROTAFLOW (MAQUET) AND ACCORDING TO THE HEALTHCARE EXECUTIVE, THE CANNULA WAS EJECTED FROM THE EQUIPMENT. THE PATIENT DIED. THE ISSUE IS LINKED TO THE COMPLAINT (B)(4). COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691029 CANNULA & CATHETER CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF MAQUET CARDIOPULMONARY GMBH BE-PAS 2115# UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death