BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D 100 PH.I.S.I.O. NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH RESERVOIR

    MDR report key: 6438397 · Received March 28, 2017

    Report

    Report Number
    9680841-2017-00010
    Event Type
    Malfunction
    Date Received
    March 28, 2017
    Date of Event
    February 24, 2017
    Report Date
    August 25, 2017
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    DTZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE D100 PH.I.S.I.O NEWBORN HOLLOW FIBER OXYGENATOR WAS A NON-STERILE COMPONENT ASSEMBLED INTO A STERILE CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT INTO WHICH THE OXYGENATOR WAS ASSEMBLED. AS THE STERILE FINISHED PRODUCT IS NOT DISTRIBUTED IN THE USA, THERE IS NO UNIQUE IDENTIFIER (UDI) NUMBER. HOWEVER, THE INVOLVED DEVICE IS SIMILAR TO D100 PH.I.S.I.O NEWBORN HOLLOW FIBER OXYGENATOR CATALOG NUMBER 050531, WHICH IS DISTRIBUTED IN THE USA, FOR WHICH THE DEVICE IDENTIFIER IS (B)(4). THE AGE OF THE DEVICE WAS CALCULATED AS THE TIME ELAPSED FROM DEVICE STERILIZATION AND THE DATE OF EVENT. (B)(4). THE D100 PH.I.S.I.O NEWBORN HOLLOW FIBER OXYGENATOR WAS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA. THE STAND ALONE OXYGENATOR (CATALOG NUMBER 050531) IS REGISTERED IN THE USA (510(K) NUMBER: K061031). 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 D100 PH.I.S.I.O NEWBORN HOLLOW FIBER OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6). PER EXEMPTION NUMBER E2016005, SORIN GROUP (B)(4). IS SUBMITTING THE REPORT FOR BOTH SORIN GROUP (B)(4) (MANUFACTURER) AND (B)(4). (IMPORTER). THE CUSTOMER HAS NOT CLARIFIED THE ACTUAL PATIENT HEALTH CONDITION. SEVERAL ATTEMPTS HAVE BEEN MADE TO CONTACT THE CUSTOMER FOR ADDITIONAL INFORMATION ABOUT THE EVENT AND THE INVOLVED PATIENT. HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. THE INVOLVED DEVICE HAS BEEN REQUESTED FOR RETURN TO SORIN GROUP (B)(4) FOR INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    PER EXEMPTION NUMBER E2016005. (B)(4). THE INVOLVED DEVICE WAS RETURNED TO SORIN GROUP ITALIA FOR INVESTIGATION. DURING VISUAL INSPECTION, NO VISIBLE DEFECTS WERE NOTED. A GAS TRANSFER TEST WAS CONDUCTED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) WITH BLOOD SAMPLES FROM BOTH THE VENOUS AND THE ARTERIAL SITE. THE VALUES OF O2 TRANSFERRED AND THE MEASURED PRESSURE DROP WERE WITHIN THE EXPECTED RANGE. A SLIGHT DECREASE OF THE CO2 TRANSFERRED VALUE WAS OBSERVED, HOWEVER THIS IS EXPECTED AS THE DEVICE HAS ALREADY BEEN USED WITH BLOOD AND HAS A DEPOSITION OF BIOLOGICAL SUBSTANCE ON THE FIBER BUNDLE. ACCORDING TO THE TEST RESULTS AND ABOVE MENTIONED EVALUATIONS, THE INVOLVED DEVICE WAS CONSIDERED TO HAVE BEEN PROPERLY MANUFACTURED AND RELEASED IN COMPLIANCE TO THE RELEVANT TECHNICAL SPECIFICATIONS. SORIN GROUP ITALIA HAS CONCLUDED THAT THE EVENT IS NOT RELATED TO A DEVICE MALFUNCTION.

    Description of Event or Problem · 0

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT OXYGEN WAS NOT SUPPLIED TO THE D 100 PH.I.S.I.O. OXYGENATOR FOR UNKNOWN REASONS DURING A PROCEDURE, AND THE BLOOD WAS NOT OXYGENATED SUFFICIENTLY. THE SATURATION DROPPED AND DID NOT RISE BACK UP. A LIFE-THREATENING CONDITION APPEARED AND THE PATIENT WAS PLACED ON ARTIFICIAL LUNG VENTILATION. THE PATIENT IS NOW IN INTENSIVE CARE IN CRITICAL CONDITION. THE EXTENT OF THE DAMAGE SUFFERED IS UNKNOWN AND THE DOCTORS HAVE IMPLEMENTED LIFE-SUPPORT MEASURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221472 D 100 PH.I.S.I.O. NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH RESERVOIR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA S.R.L. 1611160125

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO Life Threatening