BEUDAMED
    FDA Adverse Event Death Summary report: N

    CANNULA & CATHETER

    MDR report key: 11693278 · Received April 20, 2021

    Report

    Report Number
    8010762-2021-00258
    Event Type
    Death
    Date Received
    April 20, 2021
    Report Date
    July 12, 2021
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DWF
    PMA / PMN Number
    K102532
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A HLS VENOUS CANNULA CONNECTOR CRACKED WHILE INSERTED WITHIN A PATIENT FOR APPROXIMATELY 55 DAYS. CUSTOMER ADVISED THAT THE PATIENT WAS TURNED BY HOSPITAL STAFF AND WHEN THIS OCCURRED THE CONNECTOR CRACKED. HE ADVISED THAT WHEN THE CONNECTOR CRACKED THE CIRCUIT ENTRAINED AIR AND THE PUMP STOPPED. HE ADVISED THAT PRESSURE WAS APPLIED TO THE CANNULA SITE BUT THAT THE PATIENT WAS BLEED THROUGH THE CRACK IN THE CANNULA. PATIENT EXPIRED. MAQUET CARDIOPULMONARY REQUESTED THE PRODUCT BACK FOR INVESTIGATION IN THE LABORATORY OF MANUFACTURER. THE PRODUCT IS NOT AVAILABLE FOR INVESTIGATION AS IT WAS DISCARDED BY THE CUSTOMER. THE RELEVANT INFORMATION (PRODUCT INFORMATION, EVENT DETAILS AND RELATION WITH THE MAQUET DEVICE) WAS REQUESTED ON (B)(6) 2021. THE INFORMATION WAS RECEIVED ON (B)(6) 2021. THE MEDICAL REVIEW SHOWS, THE EXPIRATION OF THE PATIENT APPEARS TO BE DIRECTLY RELATED TO AN INADVERTENT MISHANDLING OF THE PRODUCT DURING TURNING/REPOSITIONING OF THE PATIENT RATHER THAN TO AN INHERENT DEFECT OR MALFUNCTION OF THE PRODUCT, PER SE. IT IS LIKELY THAT EXTRAORDINARY STRESS AND/OR TORQUE WAS INADVERTENTLY APPLIED TO THE CANNULA DURING THE TURNING MANEUVER, RESULTING IN A FRACTURE OF THE CANNULA. STRESS AND/OR TORQUE TO THE CANNULA ALSO MAY HAVE BEEN EXACERBATED THROUGH REPEATED TURNING (REPOSITIONING) OF THE PATIENT OVER THE PERIOD OF 55 DAYS, I.E. IF MULTIPLE OCCASIONS OF REPOSITIONING/TURNING OCCURRED. THE HLS CANNULA INSTRUCTIONS FOR USE STATES THE INTENDED USE PERIOD FOR THE PRODUCT IS 6 HOURS (INSTRUCTIONS FOR USE CATHETERS & CANNULAE HLS CANNULAE SET G-639 70105.3080). IT IS CHALLENGING TO DISCERN IF THE DWELL TIME OF 55 DAYS INFLUENCED THE STRUCTURAL INTEGRITY OF THE CANNULA (I.E. THROUGH LONG TERM HEAT EXPOSURE, REPEATED TORQUE/STRESS, CANNULA REPOSITIONING, ETC.); AS THE VERIFICATION TESTS OF THE CANNULAE ARE PERFORMED TO COVER THE MAXIMUM APPLICATION TIME OF 30 DAYS. MOREOVER, THERE WAS NO INDICATION FROM THE COMPLAINT NARRATIVE OF ANY DIMINUTION OF, OR NEGATIVE INFLUENCE ON, STRUCTURAL INTEGRITY OR PERFORMANCE. MOREOVER, THE EXPIRATION OF THE PATIENT APPEARS TO BE DIRECTLY RELATED TO AN INADVERTENT MISHANDLING OF THE PRODUCT DURING TURNING/REPOSITIONING OF THE PATIENT RATHER THAN TO AN INHERENT DEFECT OR MALFUNCTION OF THE PRODUCT, PER SE. THE CAUSE OF THE REPORTED FAILURE COULD BE ASSOCIATED WITH THE MANIPULATION AND/OR POSITIONING OF THE PATIENT DURING SUPPORT WITH CANNULAE IN SITU. BASED ON THIS INFORMATION, THE CAUSE OF THE EVENT COULD NOT BE ATTRIBUTED TO THE DEVICE. 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.

    Description of Event or Problem · 0

    COMPLAINT: (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING. A FOLLOW-UP MEDWATCH WILL BE SENT WHEN FURTHER INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HLS VENOUS CANNULA CONNECTOR CRACKED WHILE INSERTED WITHIN A PATIENT FOR APPROXIMATELY 55 DAYS. CUSTOMER ADVISED THAT THE PATIENT WAS TURNED BY HOSPITAL STAFF AND WHEN THIS OCCURRED THE CONNECTOR CRACKED. HE ADVISED THAT WHEN THE CONNECTOR CRACKED THE CIRCUIT ENTRAINED AIR AND THE PUMP STOPPED. HE ADVISED THAT PRESSURE WAS APPLIED TO THE CANNULA SITE BUT THAT THE PATIENT WAS BLEED THROUGH THE CRACK IN THE CANNULA. PATIENT EXPIRED. COMPLAINT#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592429 CANNULA & CATHETER CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF MAQUET CARDIOPULMONARY GMBH HLS CANNULA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death