BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIOHELP

    MDR report key: 11645174 · Received April 9, 2021

    Report

    Report Number
    3008355164-2021-00010
    Event Type
    Death
    Date Received
    April 9, 2021
    Date of Event
    March 20, 2021
    Report Date
    December 23, 2021
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K133598
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT NO FLOW WAS ACHIEVED DURING PRIMING. THE DEVICE WAS NOT BEING USED FOR TREATMENT. THE USED HLS SET IS HANDLED UNDER COMPLAINT# (B)(4) (MFG REPORT NUMBER 8010762-2021-00223). THE USER INITIALLY TRIED TO PRIME A FIRST HLS SET FOR THE SAME PATIENT BUT AS A NOISE WAS NOTED THAT HLS WAS NOT USED. THAT ISSUE IS HANDLED UNDER COMPLAINT# (B)(4) (HLS, MFG REPORT NUMBER 8010762-2021-00226) AND (B)(4) (CARDIOHELP, MFG REPORT NUMBER 8010762-2021-00240). THE CUSTOMER PROVIDED A VIDEO OF THE HLS SET IN USE. THE REPORTED NOISE WAS HEARD. DEVICE HISTORY RECORD: THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON (B)(6) 2021 FOR THE PERIOD OF (B)(6) 2014 TO (B)(6) 2021. IT DOES NOT SHOW ANY NON-CONFORMITY IN REGARD TO THE REPORTED PRODUCT AND FAILURE. THERE IS NO INDICATION THAT MANUFACTURING ISSUES OCCURRED DURING THIS TIME, THUS PRODUCTION RELATED INFLUENCES ARE UNLIKELY TO HAVE CONTRIBUTED TO THE REPORTED EVENT. THE PRODUCT IN QUESTION WAS PRODUCED IN (B)(6) 2014. PRODUCT INVESTIGATION: THE INVOLVED CARDIOHELP WAS INVESTIGATED BY A GETINGE SERVICE TECHNICIAN ON (B)(6) 2021 AND NO ISSUE COULD BE REPRODUCED. ON (B)(6) 2021 THE TECHNICIAN REPLACED THE SENSOR PANEL AND FLOW-/ BUBBLE SENSOR OF THE CARDIOHELP AS A PRECAUTION. THE LOG FILES WERE ANALYZED BY GETINGE LIFE CYCLE ENGINEERING AND NO ERRORS WERE FOUND. THE INVOLVED HLS SET AS WELL WAS TECHNICALLY INVESTIGATED AND NO MALFUNCTION OR ISSUE COULD BE DETERMINED. MEDICAL EVALUATION: A MEDICAL REVIEW WAS PERFORMED BY GETINGE MEDICAL AFFAIRS. EXAMINATIONS OF THE CARDIOHELP SYSTEM (SN (B)(6), A CH) BY GETINGE AND THE ECRI INVESTIGATION OF THE SECOND CARDIOHELP SYSTEM (SN (B)(6), B CH) WERE NOT ABLE TO DUPLICATE THE ISSUES REPORTED BY THE CUSTOMER IN THIS COMPLAINT. ADDITIONALLY, NO PERFORMANCE ISSUES WITH TWO DIFFERING DISPOSABLES (A HLS AND B HLS) COULD BE IDENTIFIED IN ECRI TESTS. MOREOVER, NO WARNINGS, DEFICIENCIES, OR LOW, MEDIUM, HIGH, CRITICAL PRIORITY ERRORS WERE SHOWN IN AN EXAMINATION OF THE USER AND SERVICE POOL INFORMATION BY LIFE CYCLE ENGINEERING. THE COMPLAINTS MENTIONED THAT THE PATIENT EXPIRED WHILE WAITING TO BE PLACED ON SUPPORT USING THE CARDIOHELP SYSTEM; HOWEVER, NO EVIDENTIARY, DIRECT (ROOT) CAUSE OF THE PATIENT¿S EXPIRATION CAN BE ASSIGNED TO A MALFUNCTION OF THE CARDIOHELP SYSTEM OR TO ITS ASSOCIATED DISPOSABLES (HLS SET). IN THE ABSENCE OF MORE DETAILS, IT REMAINS UNCLEAR IF THE EVENTS REPORTED BY THE USER (I.E. NOISE, INABILITY TO ZERO THE PRESSURE SENSORS, AND LACK OF FLOW) WERE DUE TO EITHER A SINGLE USE ERROR OR COMBINATION OF USE ERRORS. HOWEVER, THE POSSIBILITY CANNOT BE COMPLETELY DISMISSED. CONCLUSION: WHILE THE REVIEW INCLUDED AN EVALUATION OF TECHNICAL, MEDICAL, TRENDING AND DEVICE HISTORY RECORDS (MANUFACTURING); IT COULD NOT BE CONFIRMED THAT THE REPORTED FAILURES MAY BE ASSOCIATED WITH A MEDICAL DEVICE MALFUNCTION. ADDITIONALLY, THE INVESTIGATION RESULTS SUPPORTED THAT THE REPORTED FAILURE ¿NO FLOE¿ COULD NOT BE CONFIRMED. THE OCCURRENCE RATE WAS CALCULATED FOR THE REPORTED FAILURE 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 ID: (B)(4).

    Additional Manufacturer Narrative · 1

    RETURN OF PRODUCT AND FURTHER PATIENT DATA WAS REQUESTED BUT NOT YET RECEIVED. A FOLLOW-UP EMDR WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING PRIMING NO FLOW WAS ACHIEVED. WHILE SETTING UP OF THE CIRCUIT THE PATIENT EXPIRED. SEE DETAILED DESCRIPTION PROVIDED BY CUSTOMER BELOW: "(B)(6) CCP ADVISED THAT SHE SET UP THE CARDIOHELP CONSOLE WITH SERIAL NUMBER (B)(4) AND SET UP A NEW HLS CIRCUIT WITH LOT NUMBER 70142667. SHE WAS ABLE TO ZERO THE PRESSURES AND SUCCESSFULLY PRIME THE CIRCUIT VIA GRAVITY. HOWEVER SHE SAID WHEN SHE SET THE RPMS TO 3000 THERE WAS NO FLOW. SHE SET THE RPMS TO ZERO AND REMOVED THE HLS SET FROM THE PUMP DRIVE WITHOUT REMOVING THE PRESSURE & TEMPERATURE CABLE AND RETURNED THE HLS SET TO THE PUMP DRIVE. SHE SET THE RPMS TO 3000 AND STATED THAT .02 LPM SHOWED ON THE SCREEN THUS THERE WAS NO FLOW. SHE SAID THAT THERE WAS NO POSITIVE OR NEGATIVE FLOW SHOWING ON THE SYSTEM. SHE STATED THAT THE HLS SYSTEM WAS REMOVED FROM THE PRIMEBAG. THEY WERE UNABLE TO ACHIEVE ANY FLOW WITH THIS CIRCUIT. THEY ISOLATED PUMP SERIAL NUMBER (B)(4) AND HLS SET WITH LOT 70142667." PLEASE NOTE THIS CASE IS CONNECTED TO COMPLAINT#(B)(4)(INVOLVED HLS SET) WHICH WAS REPORTED UNDER EMDR#450316, 8010762-2021-00223. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541329 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Death