BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUADROX-ID ADULT OXYGENATOR WITH SOFTLINE COATING WITH SCREW CONNECTOR

    MDR report key: 9694578 · Received February 11, 2020

    Report

    Report Number
    3008355164-2020-00003
    Event Type
    Death
    Date Received
    February 11, 2020
    Date of Event
    November 14, 2019
    Report Date
    February 11, 2020
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET (B)(4) REQUESTED THE PRODUCT IN QUESTION FOR FURTHER INVESTIGATION BUT THE DISPOSABLE WAS ALREADY DISPOSED. THEREFORE NO LABORATORY INVESTIGATION COULD BE PERFORMED BY THE MANUFACTURER. A REVIEW FOR SIMILAR COMPLAINTS TO BE INVESTIGATED WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND. A MEDICAL REVIEW WAS PERFORMED ON 2020-02-06. RESULTS: THE OXYGENATOR DEVICE IN QUESTION HAS BEEN CHANGED OUT DUE TOO HIGH TRANSMEMBRANE PRESSURE (DELTA-P). IT HAS BEEN FURTHER STATED THAT THE HEPARIN SUPPLY WAS INTERMITTENT DURING THE COURSE OF THE EXTRACORPOREAL CIRCULATION. THE SCALE OF CLINICAL THERAPY WITH THE INVOLVED MEDICAL DEVICES, AS STATED ABOVE, IS POINTING TO A VERY CHALLENGING ANTICOAGULATION PROTOCOL. NEITHER FROM THE ANAMNESIS KNOWN OR PERIOPERATIVE ACQUIRED COAGULATION DISORDERS ARE KNOWN. ACCORDING TO THE INFORMATION IT IS CONCEIVABLE THAT COAGULATION DISORDERS AND SUBSEQUENT CHALLENGES WITHIN THE ANTICOAGULATION MANAGEMENT WERE PRESENT AND LED TO THE INCREASED TRANSMEMBRANE PRESSURE OF THE DEVICE IN QUESTION OR COULD HAVE PROMOTE. WITHOUT FURTHER INFORMATION NO RELIABLE CONCLUSIONS CAN BE DRAWN. THE CORRESPONDING PATIENT DID EXPIRE UNRELATED TO THE OXYGENATOR THAT WAS CHANGED ACCORDING TO THE CHIEF OF PERFUSION AT THE SITE OF THE EVENT. THUS THE FAILURE COULD NOT BE CONFIRMED. NO ROOT CAUSE COULD BE DETERMINED. THE OCCURRENCE RATE IS BELOW THE ACCEPTANCE RATE, THUS NO REMEDIAL ACTION 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 · 1

    SPOKE WITH (B)(6) CCP. HE ADVISED THE SSU THAT DURING THERAPY WITH THE OXYGENATOR THAT WAS "CHANGED OUT" WITH LOT 70132529 THE HEPARIN WAS BEING STARTED AND STOPPED DURING THERAPY. (B)(6), THE CHIEF OF PERFUSION AT (B)(6) UNIVERSITY HOSPITAL STATED: " WE JUST CHANGED OUT OXYGENATOR. DR (B)(6) WANTS US TO CONTACT MAQUET AND FIND OUT WHY THERE IS SUCH A GRADIENT. LOT 70132529: 200 MMHG (CHANGED) LOT 70133375: 130 MMHG (NEW)." NEW INFORMATION RECEIVED ON 2019-11-22 BY THE SSU: THE PATIENT EXPIRED UNRELATED TO THE OXYGENATOR THAT WAS CHANGED. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155599 QUADROX-ID ADULT OXYGENATOR WITH SOFTLINE COATING WITH SCREW CONNECTOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH HMOD 70000-USA #SQUADROX-ID ADULT O.FILT 70132529

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R