BEUDAMED
    FDA Adverse Event Death Summary report: N

    HLM TUBING SET W/BIOLINE COATING

    MDR report key: 5886737 · Received August 18, 2016

    Report

    Report Number
    8010762-2016-00520
    Event Type
    Death
    Date Received
    August 18, 2016
    Date of Event
    July 28, 2016
    Report Date
    August 16, 2017
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K101153
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CLINICAL ASSESSMENT HAS BEEN PERFORMED. THE RESULTS ARE AS FOLLOWS: THE MANUFACTURER AGREES WITH THE USERS OPINION THAT THE AIR WAS GETTING INTO THE PLS-SET BY USE ERROR HANDLING A DIFFERENT MEDICAL PRODUCT (CENTRAL VENOUS CATHETER OR PRESSURE TRANSDUCER). THE PLS-SET HAS ACT AS SPECIFIED. MAQUET CARDIOPULMONARY (B)(4) REQUESTED THE PRODUCT FOR MANUFACTURERS LABORATORY INVESTIGATION BUT HAS NOT RECEIVED IT YET. INVESTIGATION IS STILL PENDING. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED AS SOON AS FURTHER INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION: THE PRODUCT MENTIONED UNDER SECTION D IS NOT DISTRIBUTED TO THE US, BUT THE PRODUCT WITH CONTRIBUTING DESIGN FUNCTION TO THE AFFECTED COMPONENT (QUADROX-ID) IS REGISTERED UNDER 510(K): K101153.

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RETURNED TO THE SITE IN (B)(4) FOR INVESTIGATION. THE OXYGENATOR WAS DELIVERED WITHOUT THE VENOUS LINE AND IT WAS CONFIRMED BY THE SSU THAT THIS WAS UNAVAILABLE FOR RETURN. WITHOUT THIS COMPONENT, A FULL INVESTIGATION INTO THE ROOT CAUSE OF THE AIR ENTERING THE VENOUS LINE COULD NOT BE CARRIED OUT. HOWEVER A CLINICAL EVALUATION HAD ALREADY BEEN PERFORMED AND IT WAS DETERMINED THAT THE ISSUE WAS CAUSED BY USER ERROR DURING THE USE OF ANOTHER MEDICAL PRODUCT AS MENTIONED BY THE CUSTOMER IN THE FOLLOW-UP INFORMATION. THE PLS-SET HAS WORKED CORRECTLY AND THEREFORE THE FAILURE IS NOT CONFIRMED. NO SYSTEMIC ISSUE WAS IDENTIFIED FROM THE COMPLAINT DATABASE REVIEW BUT THE DATA, HOWEVER, WILL CONTINUE TO BE MONITORED AND IF A TREND OCCURS, IT WILL BE ESCALATED TO QUALITY ASSURANCE MANAGEMENT FOR REVIEW AND DETERMINATION IF FURTHER INVESTIGATION IS NECESSARY. DUE TO THIS NO FURTHER INVESTIGATION OR ACTION IS WARRANTED AT THIS TIME AND THE COMPLAINT WILL BE CLOSED. PLEASE NOTE THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    "ACCORDING TO THE SURGEON, WHICH WAS RESPONSIBLE FOR THE SURGERY, IT WAS OBSERVED AN EVENT ADVERSE, CAUSED BY AIR THAT ENTERED THE VENOUS LINE. THE DUTY PERFUSIONIST IMMEDIATELY DETECTED AIR INTO THE CIRCUIT AFTER THE WRONG OPENING THE TAP OF THE VENOUS ACCESS LINE PRESSURE TRANSDUCER." ADDITIONAL INFO: CUSTOMER THINKS THAT THE AIR WAS COMING THROUGH THE PORT OF LINE PRESSURE VENOUS ACCESS. VENOUS CANNULA 19 FR AND ARTERIAL CANNULA 17 FR WAS USED. CANNULA WAS PLACED ON FEMORAL ARTERY AND VEIN TO THE RIGHT. NO BUBBLE DETECTION WAS USED; ROTFLOW WAS USED IN MODE LPM AND RPM; A CENTRAL VENOUS ACCESS WAS EXISTING; IT WAS A ECMO ARTERIOVENOUS; CUSTOMER DOES NOT THINK THAT THE CLAIMED PRODUCT IS RESPONSIBLE FOR THE PATIENT DEATH. NO ANY OTHER ABNORMALITY WAS FOUND DURING USE. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538934 HLM TUBING SET W/BIOLINE COATING OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY AG BE-PLS 2050 70112370

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Death