BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYGENATOR

    MDR report key: 11200538 · Received January 20, 2021

    Report

    Report Number
    8010762-2021-00017
    Event Type
    Malfunction
    Date Received
    January 20, 2021
    Report Date
    April 22, 2021
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    PMA / PMN Number
    K101153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT OCCURRED IN THE US. IT WAS REPORTED THAT THE TUBING WAS DISCONNECTING FROM THE QUADROX-ID ARTERIAL OUTLET AFTER 24 HOURS OF INITIATION VA EMCO. THE TUBING SET WAS MANUFACTURED AND DISTRIBUTED BY LIVANOVA. THE OXYGENATOR AND TUBING FROM THE CUSTOMER WAS NOT AVAILABLE FOR RETURN, THUS NO TECHNICAL INVESTIGATION WAS POSSIBLE. A MEDICAL REVIEW WAS ALREADY PERFORMED FOR A SIMILAR ISSUE (REFER COMPLAINT# (B)(4)) BY GETINGE MEDICAL EXPERTS ON 2021-02-09 WITH FOLLOWING RESULTS: ¿MOST PROBABLY THE APPLIED CABLE TIE TENSION BY THE CABLE TIE GUN AT THE CONNECTOR WAS NOT SUFFICIENT. THIS COULD CAUSE A DISCONNECTION AT LOWER PRESSURES THAN EXPECTED. ANOTHER ASPECT COULD BE AN INCOMPATIBILITY OF THE QUADROX-ID IN COMBINATION WITH THE LIVANOVA TUBING WHICH MAY BE OBSERVED IN THE FOLLOWING MANNERS: AN UNEXPECTED, YET SLIGHTLY, LARGER INNER DIAMETER OF THE TUBING MAY LEAD TO GREATER POSSIBILITY OF TUBING DISCONNECTION FROM THE BARBED CONNECTOR DUE TO DECREASE IN SURFACE AREA CONTACT. A GREATER RESISTANCE, OR DECREASE IN PLIABILITY, OF THE TUBE ITSELF DUE TO A CHANGE IN TUBING SHORE (AKA DUROMETER). A CHANGE IN TUBING SHORE MAY ACCOUNT FOR A NEED TO APPLY INCREASED TENSION TO PARTICULAR TIE BAND TO ASSURE PROPER FIXATION OF THE CONNECTOR AND THE TUBING JUNCTION. THE MAQUET SOFTLINE AND BIOLINE INSTRUCTION FOR USE (INSTRUCTIONS FOR USE BIOLINE COATING, G-063, V04, CHAPTER 6.2 INTERACTIONS WITH OTHER SUBSTANCES) STATE THE FOLLOWING WITH RESPECT TO THE USE OF DIFFERING COATINGS: ¿INTERACTIONS BETWEEN SOFTLINE COATING [OR BIOLINE COATINGS] AND COATINGS FROM OTHER MANUFACTURERS ARE UNHEARD OF, BUT CANNOT BE RULED OUT. THEREFORE, DEVICES COATED WITH SOFTLINE COATING MUST NOT BE COMBINED WITH SYSTEMS FEATURING OTHER COATINGS. COMBINATIONS OF MAQUET COATINGS CAN BE USED WITHOUT ANY PROBLEMS¿. THE PRODUCTION RECORDS OF THE AFFECTED QUADROX-ID MODULE WERE REVIEWED ON 2021-04-14. ACCORDING TO THE FINAL TEST RESULTS, ALL OXYGENATORS PASSED THE TESTS AS PER SPECIFICATIONS. PRODUCTION RELATED INFLUENCES CAN BE EXCLUDED. IN ACCORDANCE WITH THE QUADROX-ID RISK ANALYSIS FOLLOWING PROBABLE ROOT CAUSES WERE DETERMINED: LACK OF ATTENTION ON DEVICE HANDLING, INAPPROPRIATE FIXATION. BASED ON THE INVESTIGATION RESULTS NO PRODUCT RELATED MALFUNCTION COULD BE CONFIRMED THE OCCURRENCE RATE WAS CALCULATED FOR THE REPORTED ISSUE 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

    A FOLLOW UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM A CUSTOMER FROM THE US THAT CUSTOMER USING THE HMOD 70000 OXYGENATOR AND DURING A ECLS CASE THE ARTERIAL LINE CAME OFF THE ARTERIAL END OF THE QUADROX. THEY MANAGED TO GET THE LIVANOVA TUBING LINE BACK ON THE QUADROX AND THEY CONTINUED SUPPORT FOR THE PATIENT. THE TUBING WAS ZIPPED TIED ON TO THE QUADROX. NO INDICATION OF ACTUAL OR POTENTIAL FOR HARM OR DEATH REPORTED. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96745 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH BEQ-HMOD70000-USA #SQUADROX-ID AD.O.FIL. 70124600

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR