BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBE CARDIOVASCULAR REVOLUTION@ CENTRIFUGAL BLOOD PUMP WITH PC COATING

    MDR report key: 8381471 · Received March 1, 2019

    Report

    Report Number
    9680841-2019-00008
    Event Type
    Malfunction
    Date Received
    March 1, 2019
    Date of Event
    January 30, 2019
    Report Date
    April 24, 2019
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    KFM
    UDI-DI
    08033178104791
    PMA / PMN Number
    K030462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SORIN GROUP ITALIA MANUFACTURES THE REVOLUTION CENTRIFUGAL BLOOD PUMP . THE INCIDENT OCCURRED IN SAPPORO; JAPAN. 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 COMPLAINED REVOLUTION PUMP WAS RETURNED TO SORIN ITALIA FOR INVESTIGATION. INSPECTION OF THE PUMP CONFIRMED THE OUTLET CONNECTOR WAS COMPLETELY BROKEN OFF. THE RETURNED UNIT WAS INVESTIGATED FOR THE PRESENCE OF POSSIBLE RESIDUAL MOLD-IN STRESS THAT MIGHT FACILITATE THE COMPLAINED BREAK. OUR LABORATORY TEST DID NOT HIGHLIGHT ANY RESIDUAL MOLD-IN STRESS THUS CONFIRMING THE BREAK WAS NOT ASCRIBABLE TO THE DEVICE MANUFACTURING. DHR VERIFICATION DID NOT REVEAL ANY RELEVANT INFORMATION POSSIBLY LINKED WITH THE CLAIMED DEFECT. LIVANOVA BELIEVES THAT THE MOST PROBABLE ROOT CAUSE OF THE BREAK WAS A MECHANICAL STRESS DURING TRANSPORTATION. AS THE FREQUENCY OF THIS TYPE OF EVENT IS LOW AND THE ROOT CAUSE WAS NOT ASCRIBABLE TO A DEVICE PROBLEM, NO CORRECTIVE ACTION WILL BE UNDERTAKEN. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Additional Manufacturer Narrative · 0

    THE EVENT OCCURRED BEFORE ANY PATIENT INVOLVEMENT. THE AGE OF THE DEVICE WAS CALCULATED AS THE TIME ELAPSED BETWEEN DEVICE STERILIZATION AND THE DATE OF THE EVENT. PER EXEMPTION NUMBER E2016005. 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.

    Description of Event or Problem · 0

    SORIN GROUP (B)(4) HAS RECEIVED A REPORT THAT, DURING CIRCUIT SETUP, THE BLOOD OUT CONNECTOR OF THE CENTRIFUGAL PUMP REVOLUTION COMPLETELY BROKEN OFF. THE EVENT OCCURRED PRIOR TO ANY PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175150 COBE CARDIOVASCULAR REVOLUTION@ CENTRIFUGAL BLOOD PUMP WITH PC COATING CENTRIFUGAL BLOOD PUMP KFM SORIN GROUP ITALIA SRL PC 1811050025 08033178104791

    Patients

    Seq Age Sex Outcome Treatment
    1