BEUDAMED
    FDA Adverse Event Summary report: N

    COBE CARDIOVASCULAR REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING

    MDR report key: 5469398 · Received February 29, 2016

    Report

    Report Number
    9680841-2016-00496
    Date Received
    February 29, 2016
    Date of Event
    July 8, 2016
    Report Date
    July 8, 2016
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    KFM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALERT DATE CONTAINED IN THE INITIAL REPORT WAS INCORRECT. THE EVENT WAS MADE REPORTABLE AFTER RECEIVING A NOTIFICATION ON FEBRUARY 4, 2016 THAT THE CUSTOMER REPORTED THE EVENT TO THE LOCAL COMPETENT AUTHORITY. THE CORRECT ALERT DATE FOR THE INITIAL MEDWATCH REPORT IS FEBRUARY 4, 2015.

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI) NUMBER: NO UDI BECAUSE THE DEVICE IS NOT SOLD OR DISTRIBUTED IN USA. THE COMPLAINED REVOLUTION CENTRIFUGAL BLOOD PUMP CATALOG NUMBER IS NOT DISTRIBUTED IN THE USA, HOWEVER THE REVOLUTION CENTRIFUGAL BLOOD PUMP IS DISTRIBUTED IN THE USA AS A STAND ALONE STERILE DEVICE UNDER CATALOG NUMBER 050300700 (510(K) NUMBER: K030462). SORIN GROUP (B)(4) MANUFACTURES THE CENTRIFUGAL BLOOD PUMP. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT, WHILE ASSEMBLING THE TUBING DURING SET UP OF THE CIRCUIT, THE BLOOD OUTLET PORT OF THE REVOLUTION CENTRIFUGAL BLOOD PUMP WAS FOUND TO BE COMPLETELY BROKEN OFF. THERE WAS NO PATIENT INVOLVEMENT. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. THE INVESTIGATION IS ON-GOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION WILL BE COMPLETED.

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS ORIGINALLY SUBMITTED ON DECEMBER 22, 2016. HOWEVER, DUE TO A "DUPLICATE REPORT" ERROR, THE SUBMISSION WAS REJECTED. THROUGH COMMUNICATION WITH THE FDA AND A REVIEW OF PREVIOUSLY FILED REPORTS, IT WAS DISCOVERED THAT THE ERROR WAS CAUSED BECAUSE A DIFFERENT REPORT, 9680841-2016-00108 FOLLOW-UP 1, WAS ERRONEOUSLY FILED AS 9680841-2016-00496 FOLLOW-UP 1 ON FEBRUARY 29, 2016. THIS ERROR WAS MADE BECAUSE THE COMPLAINT NUMBER FOR REPORT 9680841-2016-00108 REPORT IS 2016-00496. IN ORDER TO SUBMIT THIS REPORT WITHOUT THE "DUPLICATE REPORT" ERROR PREVENTING THE SUBMISSION FROM BEING ACCEPTED, IT IS BEING SUBMITTED AS FOLLOW-UP 2. THE FIRST FOLLOW-UP REPORT FOR 9680841-2016-00496 (SUBMITTED ON FEBRUARY 29, 2016) IS ERRONEOUS AND CONTAINS INFORMATION RELATED TO A DIFFERENT COMPLAINT. A CORRECTION HAS ALSO BEEN FILED FOR REPORT 9680841-2016-00108. THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP 2 DUE TO A "DUPLICATE REPORT" ERROR (SEE ABOVE). HOWEVER, IT IS ACTUALLY THE FIRST FOLLOW-UP REPORT AND SHOULD ACT AS A REPLACEMENT FOR THE EXISTING FOLLOW-UP 1 REPORT, WHICH WAS SUBMITTED WITH THE INCORRECT REPORT NUMBER ON FEBRUARY 29, 2016. SORIN GROUP (B)(4) MANUFACTURES THE CENTRIFUGAL BLOOD PUMP. THE INCIDENT OCCURRED IN (B)(6). THE DEVICE WAS RETURNED TO SORIN GROUP (B)(4) FOR INVESTIGATION. VISUAL INSPECTION OF THE RETURNED PUMP CONFIRMED THAT THE BLOOD OUTLET CONNECTOR WAS COMPLETELY BROKEN OFF. FURTHER INSPECTION REVEALED IRREGULARITIES IN THE CRACK LINE. BASED ON THE PROFILE OF THE CRACK, AND BECAUSE NO ISSUES WERE IDENTIFIED IN THE DHR, SORIN GROUP (B)(4) HAS CONCLUDED THAT THE MOST PROBABLE ROOT CAUSE IS ROUGH HANDLING DURING TRANSPORTATION. DESPITE THE LOW DEFECT RATE FOR THIS TYPE OF ISSUE, SORIN GROUP (B)(4) HAS OPENED A CAPA PROJECT TO IDENTIFY POSSIBLE CORRECTIVE ACTIONS TO FURTHER DECREASED THE OCCURRENCE RATE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT, WHILE ASSEMBLING THE TUBING DURING SET UP OF THE CIRCUIT, THE BLOOD OUTLET PORT OF THE REVOLUTION CENTRIFUGAL BLOOD PUMP WAS FOUND TO BE COMPLETELY BROKEN OFF. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126064 COBE CARDIOVASCULAR REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM SORIN GROUP ITALIA 1604290164

    Patients

    Seq Age Sex Outcome Treatment
    1