BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADROX-ID ADULT O.FILT

    MDR report key: 11063605 · Received December 23, 2020

    Report

    Report Number
    8010762-2020-00454
    Event Type
    Malfunction
    Date Received
    December 23, 2020
    Date of Event
    October 15, 2020
    Report Date
    April 22, 2021
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    PMA / PMN Number
    K150267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A TUBING WAS DISCONNECTING FROM THE QUADROX-ID OUTLET. UNDER #406012 (8010762-2020-00451) AND #406348 (8010762-2020-00454) THE SAME CUSTOMER REPORTED SIMILAR EVENTS. THE TUBING WAS MANUFACTURED AND DISTRIBUTED BY LIVANOVA. THE CUSTOMER DISPOSED THE OXYGENATOR AND TUBING, 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 PROBABLE THE APPLIED CABLE TIE TENSION BY THE CABLE TIE GUN AT THE CONNECTION BETWEEN THE TUBING AND OXYGENATOR OUTLET 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 BIOLINE INSTRUCTION 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 BIOLINE COATINGS AND COATINGS FROM OTHER MANUFACTURERS ARE UNHEARD OF, BUT CANNOT BE RULED OUT. THEREFORE, DEVICES COATED WITH BIOLINE COATING MUST NOT BE COMBINED WITH SYSTEMS FEATURING OTHER COATINGS. COMBINATIONS OF MAQUET COATINGS CAN BE USED WITHOUT ANY PROBLEMS¿. THE CUSTOMER CONFIRMED ON 2021-03-12 THAT THEY NEVER PUT CABLE TIES ON THE OUTLET ALTHOUGH CABLE TIES WERE PROVIDED. THE CUSTOMER SUSPECTED THAT NEW EMPLOYEES IN THE HOSPITAL DID NOT PUT ON THE TUBING FAR ENOUGH ON THE CONNECTOR. IN ACCORDANCE WITH THE QUADROX-ID RISK ANALYSIS FOLLOWING MOST PROBABLE ROOT CAUSES WERE DETERMINED AS: 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 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. H3 OTHER TEXT : 4115.

    Description of Event or Problem · 0

    COMPLAINT ID: (B)(4)

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CHIEF OF PERFUSION REPORTED THAT THE LIVA NOVA CIRCUIT 3/8" TUBING BECAME DISCONNECTED FROM THE ARTERIAL OUTLET OF THE OXYGENATOR. NO PATIENT ADVERSE EFFECT WAS EXPERIENCED BY PATIENT. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1531796 QUADROX-ID ADULT O.FILT OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH N/I

    Patients

    Seq Age Sex Outcome Treatment
    1