BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR

    MDR report key: 7649500 · Received June 29, 2018

    Report

    Report Number
    9680841-2018-00016
    Event Type
    Malfunction
    Date Received
    June 29, 2018
    Date of Event
    June 4, 2018
    Report Date
    November 14, 2018
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    UDI-DI
    08033178100304
    PMA / PMN Number
    K971877
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT IDENTIFIER WAS NOT PROVIDED. THE AGE OF THE DEVICE WAS CALCULATED AS THE TIME ELAPSED BETWEEN DEVICE STERILIZATION AND THE DATE OF THE EVENT. PER EXEMPTION NUMBER E2016005. 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; DEVICE NOT YET RETURNED.

    Additional Manufacturer Narrative · 0

    SORIN GROUP ITALIA MANUFACTURES THE LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR. THE INCIDENT OCCURRED IN BELGAUM, KARNATAKA, INDIA. 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 OXYGENATOR WAS RETURNED TO SORIN GROUP ITALIA FOR INVESTIGATION FREE OF ANY BLOOD CONTAMINATION/RESIDUALS. ATTEMPTS WERE MADE TO IDENTIFY WHICH CHEMICAL OR PROCEDURES WERE UTILIZED TO CLEAN THE OXYGENATOR. HOWEVER, THESE ATTEMPTS WERE UNSUCCESSFUL. THE OXYGENATOR WAS SUBJECTED TO FUNCTIONAL TESTING WITH BOVINE BLOOD. THE RESULTS OF THE GAS TRANSFER PERFORMANCE WERE FOUND TO BE IN LINE WITH THE PRODUCT SPECIFICATIONS. THE OXYGENATOR PERFORMED AS EXPECTED. A DHR VERIFICATION DID NOT REVEAL ANY RELEVANT INFORMATION POSSIBLY LINKED WITH THE REPORTED DEFECT. THE REPORTED LOT HAS NOT BEEN INVOLVED IN ANY OTHER COMPLAINT. AS THE ISSUE COULD NOT BE REPRODUCED, THE ROOT COULD NOT BE DETERMINED, AND CORRECTIVE ACTIONS WERE NOT IDENTIFIED.

    Description of Event or Problem · 0

    SORIN GROUP ITALIA RECEIVED A REPORT THAT THE PO2 VALUES DROPPED TO 43.6 MMHG AND BLOOD DROPLETS WERE NOTICED COMING OUT FROM THE LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR GAS VENT PORT 10 MINUTES INTO A PROCEDURE. THE MEDICAL TEAM ELECTED TO CHANGE OUT THE OXYGENATOR AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES. DURING FOLLOW-UP COMMUNICATION WITH THE CUSTOMER, THE PATIENT DEVELOPED SEPSIS AND THE ICU STAY WAS PROLONGED 14 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495290 LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA D902 1709210228 08033178100304

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Hospitalization