BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORMA (PRIMO2X) ADULT HOLLOW FIBER MEMBRANE OXYGENATOR

    MDR report key: 7305566 · Received March 1, 2018

    Report

    Report Number
    9680841-2018-00006
    Event Type
    Malfunction
    Date Received
    March 1, 2018
    Date of Event
    January 31, 2018
    Report Date
    June 12, 2018
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO PATIENT INFORMATION HAS BEEN PROVIDED. THE PERFORMA (PRIMO2X) ADULT HOLLOW FIBER MEMBRANE OXYGENATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT INTO WHICH THE OXYGENATOR WAS ASSEMBLED. (B)(4). THE AGE OF THE DEVICE WAS CALCULATED AS THE TIME ELAPSED BETWEEN DEVICE STERILIZATION AND THE DATE OF EVENT. (B)(4). THE INVOLVED PERFORMA (PRIMO2X) ADULT HOLLOW FIBER MEMBRANE OXYGENATOR IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE STAND ALONE OXYGENATOR (CATALOG NUMBER 050533) IS ALSO REGISTERED IN THE USA (510(K) NUMBER: K050447). THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED CONVENIENCE PACK INTO WHICH THE OXYGENATOR WAS ASSEMBLED. SORIN GROUP (B)(4) MANUFACTURES THE PERFORMA (PRIMO2X) ADULT HOLLOW FIBER MEMBRANE OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6). PER EXEMPTION NUMBER E2016005. ON FEBRUARY 26, 2018, SORIN GROUP (B)(4) RECEIVED A USER MEDWATCH REPORT (MW5075035) RELATED TO THIS ISSUE. IT IS UNCLEAR FROM THE DETAILS IN THE USER REPORT IF THIS EVENT RESULTED IN A PATIENT INJURY. THE INVOLVED DEVICE HAS BEEN REQUESTED FOR RETURN TO SORIN GROUP (B)(4) FOR INVESTIGATION. AN UNUSED DEVICE FROM THE SAME LOT NUMBER HAS BEEN RETURNED BY THE CUSTOMER. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    SORIN GROUP ITALIA MANUFACTURES THE PERFORMA (PRIMO2X) ADULT HOLLOW FIBER MEMBRANE OXYGENATOR. THE INCIDENT OCCURRED IN YORK, PENNSYLVANIA. PER EXEMPTION NUMBER E2016005, SORIN GROUP ITALIA S.R.L. IS SUBMITTING THE REPORT FOR BOTH SORIN GROUP ITALIA S.R.L (MANUFACTURER) AND LIVANOVA USA., INC. (IMPORTER). THE INVOLVED DEVICE WAS NOT MADE AVAILABLE FOR INVESTIGATION. HOWEVER, A UNIT FROM THE SAME LOT WAS MADE AVAILABLE FOR RETURN TO SORIN GROUP ITALIA FOR INVESTIGATION. THE RETURNED DEVICE WAS TESTED FOR LEAKAGE FROM THE BLOOD SIDE TO THE WATER SIDE OF THE HEAT EXCHANGER. NO LEAK WAS OBSERVED DURING TESTING. THE DEVICE WAS FOUND TO BE CONFORMING TO SPECIFICATIONS. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. AS THE ISSUE COULD NOT BE CONFIRMED, A ROOT CAUSE WAS NOT IDENTIFIED. DEVICE FROM SAME LOT RETURNED.

    Description of Event or Problem · 0

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT A PINK COLORING WAS NOTICED IN THE NORMALLY CLEAR WATER LINES CONNECTING THE HEATER-COOLER UNIT TO THE OXYGENATOR AFTER REWARMING, INDICATING A POSSIBLE BLOOD TO WATER LEAK. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150079 PERFORMA (PRIMO2X) ADULT HOLLOW FIBER MEMBRANE OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA S.R.L. 1706050160

    Patients

    Seq Age Sex Outcome Treatment
    1