BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLM TUBING SET W/SOFTLINE COATING

    MDR report key: 6198531 · Received December 22, 2016

    Report

    Report Number
    8010762-2016-00735
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Date of Event
    November 25, 2016
    Report Date
    June 29, 2017
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWF
    PMA / PMN Number
    K090533
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WAS DISCARDED BY THE HOSPITAL AND WAS UNAVAILABLE FOR RETURN. THEREFORE, A FULL INVESTIGATION COULD NOT BE PERFORMED. A DHR REVIEW WAS PERFORMED BASED ON THE AVAILABLE INFORMATION. THE DHR OF THE AFFECTED PACKAGING LOT WAS INSPECTED AND 432 UNITS OF OXYGENATOR QUADROX-I HMO 71000 HAVE BEEN MANUFACTURED FROM 2016-03-18 UNTIL 2016-03-30 WITH NO ABNORMALITIES OR NONCONFORMITIES IN THE DHR. THE ROOT CAUSE COULD NOT BE ESTABLISHED. 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 HOSPITAL: "DURING AN AORTIC VALVE REPLACEMENT ASSOCIATED WITH CORONARY BYPASS SURGERY ON A (B)(6) PATIENT, A BLOOD LEAK WAS NOTICED AT THE CAP OF THE OXYGENATOR ON THE EXTRACORPOREAL CIRCUIT. THIS LEAK STARTED AT THE BEGINNING OF THE ECC PROCEDURE AND HAS LASTED THE ENTIRE DURATION OF THE PROCEDURE (ABOUT 1 H TO 1H30). THE APPROXIMATE FLOW RATE OF THE LEAK WAS 5 DROPS/MINUTE, WITHOUT BLOOD PROJECTION. NO CONSEQUENCE FOR THE PATIENT. BUT IF THE LEAK MOVED TO THE OXYGENATOR, THERE WOULD HAVE BEEN A RISK OF GAS EMBOLISM REQUIRING THE OXYGENATOR TO BE CHANGED, WHICH IS AN ULTIMATE PROCEDURE BECAUSE IT CARRIES A VITAL RISK FOR THE PATIENT. THE DEVICE HAS BEEN RETAINED FOR EXPERTISE." (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849172 HLM TUBING SET W/SOFTLINE COATING CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF MAQUET CARDIOPULMONARY AG BO-HQV 39600 92189290

    Patients

    Seq Age Sex Outcome Treatment
    1