BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYGENATOR HOLDER

    MDR report key: 12196715 · Received July 20, 2021

    Report

    Report Number
    3003752502-2021-00010
    Event Type
    Malfunction
    Date Received
    July 20, 2021
    Date of Event
    June 23, 2021
    Report Date
    October 18, 2021
    Manufacturer
    EUROSETS S.R.L.
    Product Code
    KRI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE PRODUCTION DOCUMENTATION FOR THE AMG PMP OXYGENATOR HOLDER, LOT 6261900, WAS REVIEWED BY THE EXTERNAL MANUFACTURER (EUROSETS) AND SHOWED THAT ALL TESTS FROM THE PRODUCTION PROCESS WERE COMPLIANT WITH THE TECHNICAL SPECIFICATIONS. THE EUROSETS AMG PMP INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. THIS DOCUMENT CONTAINS THE FOLLOWING WARNING: ¿BEFORE USING THE PRODUCT IT IS ADVISABLE TO CAREFULLY INSPECT IT. SHIPPING AND HANDLING COULD CAUSE STRUCTURAL AND FUNCTIONAL DAMAGE TO THE DEVICE.¿ THE EUROSETS OXY MODULE AMG PMP HOLDER INSTRUCTIONS FOR USE (IFU) IS ALSO CURRENTLY AVAILABLE. UNDER THE SECTIONS TITLED ¿INSTALLING THE AMG PMP OXY MODULE HOLDER¿ AND ¿FITTING THE KNOBS¿, THIS DOCUMENT INSTRUCTS THE USER ON HOW TO ASSEMBLE THE HOLDER AND ENSURE ALL THE KNOBS AND SCREWS ARE IN PLACE. THE REPORT OF A BROKEN SCREW WAS CONFIRMED THROUGH THE EVALUATION OF THE RETURNED AMG PMP OXYGENATOR HOLDER; HOWEVER A SPECIFIC CAUSE FOR THE DAMAGE COULD NOT BE CONCLUSIVELY DETERMINED. THE EUROSETS OXYGENATOR HOLDER, LOT 6261900, WAS RETURNED TO ABBOTT AND AN INITIAL VISUAL INSPECTION CONFIRMED THAT A SCREW CAP HAD BROKEN OFF ONE OF THE SCREWS. THE THREADED PORTION OF THE SCREW WAS RETURNED IN THE THREADED INSERT ON THE HOLDER. THE REMAINING SCREWS WERE SITUATED IN THEIR INTENDED LOCATIONS AND COULD BE TIGHTENED AND LOOSENED WITHOUT ISSUE. THE OXYGENATOR HOLDER WAS FORWARDED TO THE EXTERNAL MANUFACTURER (EUROSETS) FOR TECHNICAL ANALYSIS. THE BROKEN SCREW WAS DETERMINED TO BE AN ISOLATED EVENT BECAUSE NO PRIOR RELATED COMPLAINTS HAVE BEEN REPORTED ON THIS DEVICE. THE PRODUCTION DOCUMENTATION FOR THE OXYGENATOR HOLDER, LOT 6261900, WAS REVIEWED BY EUROSETS AND SHOWED THAT ALL TESTS FROM THE PRODUCTION PROCESS WERE COMPLIANT WITH THE TECHNICAL SPECIFICATIONS. THE SPECIFIC ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER EUROSETS DETERMINED THAT THE DAMAGE COULD HAVE BEEN INDUCED BY A VIOLENT IMPACT DURING THE TRANSPORT PROCESS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NEW AMG OXYGENATOR HOLDER HAD A BROKEN SCREW ON THE HINGE UPON UNBOXING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097503 OXYGENATOR HOLDER ACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS KRI EUROSETS S.R.L. US2257 6261900

    Patients

    Seq Age Sex Outcome Treatment
    1