BEUDAMED
    FDA Adverse Event Summary report: N

    ECC.O SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL

    MDR report key: 5468806 · Received February 29, 2016

    Report

    Report Number
    9680841-2016-00497
    Date Received
    February 29, 2016
    Date of Event
    August 4, 2016
    Report Date
    August 11, 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

    THERE WAS NO PATIENT INVOLVEMENT. THE MINI BYPASS PUMP HEAD IS A COMPONENT OF THE OXYGENATOR ECC.O. THE OXYGENATOR WAS ASSEMBLED INTO A CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN USA. THE OXYGENATOR IS DISTRIBUTED IN USA. BRAND NAME AND COMMON DEVICE NAME REFER TO THE ECC.O OXYGENATOR. THE CATALOG NUMBER, LOT NUMBER, AND EXPIRATION DATE REFER TO THE STERILE FINISHED PRODUCT INTO WHICH THE OXYGENATOR AND MINI BYPASS PUMP HEAD WERE ASSEMBLED. AS THE STERILE FINAL PRODUCT IS NOT DISTRIBUTED IN USA, THERE IS NO UNIQUE IDENTIFIER (UDI) NUMBER. THE MINI BYPASS PUMP HEAD IS A NON-STERILE COMPONENT OF THE ECC.O OXYGENATOR, WHICH WAS ASSEMBLED INTO A CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA. THE STAND ALONE OXYGENATOR IS REGISTERED IN THE USA (510(K) NUMBER: K050890). SORIN GROUP (B)(4) MANUFACTURES THE ECC.O OXYGENATOR AND MINI BYPASS PUMP HEAD. THE INCIDENT OCCURRED IN ST DENIS, FRANCE. THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT A LEAK WAS DETECTED IN THE MINI BYPASS PUMP HEAD OF THE ECC.O OXYGENATOR DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. ON AUGUST 11, 2016, SORIN GROUP (B)(4) WAS NOTIFIED THAT THE USER FACILITY HAD SUBMITTED A REPORT TO THE LOCAL COMPETENT AUTHORITY. THIS MEDWATCH REPORT IS BEING FILED IN RESPONSE TO THIS ACTION. 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, 9680841-2016-00107 FOLLOW-UP 1, WAS ERRONEOUSLY FILED AS 9680841-2016-00497 FOLLOW-UP 1 ON FEBRUARY 29, 2016. THIS ERROR WAS MADE BECAUSE THE COMPLAINT NUMBER FOR REPORT 9680841-2016-00107 REPORT IS 2016-00497. 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 9680841-2016-00497 (SUBMITTED ON FEBRUARY 29, 2016) IS ERRONEOUS AND CONTAINS INFORMATION RELATED TO A DIFFERENT COMPLAINT. A CORRECTION HAS ALSO BEEN FILED FOR REPORT 9680841-2016-00107. 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 ECC.O OXYGENATOR AND MINI BYPASS PUMP HEAD. THE INCIDENT OCCURRED IN (B)(6). THE COMPLAINED ECC.O SYSTEM (CENTRIFUGAL PUMP CONNECTED BY TUBING TO THE OXYGENATING MODULE, BOTH HELD TOGETHER BY A SPECIFICALLY DESIGNED TRAY) WAS RETURNED TO SORIN GROUP (B)(4) FOR INVESTIGATION. LEAK TESTING OF THE RETURNED ECC.O SYSTEM CONFIRMED A LEAK AT THE CONNECTION BETWEEN THE PUMP AND THE TUBING. MICROSCOPIC INSPECTION CONFIRMED THAT THE ORIGIN OF THE LEAK WAS A SMALL CRACK IN THE TUBING. NO SIMILAR COMPLAINTS HAVE BEEN LOGGED RELATED TO THE ECC.O SYSTEM AND ITS COMPONENTS. DUE TO THE VERY LOW FREQUENCY AND THE LOW RISK LEVEL ASSOCIATED WITH THIS TYPE OF LEAKAGE, NO FURTHER INVESTIGATION IS REQUIRED. SORIN GROUP (B)(4) WILL CONTINUE TO MONITOR FOR TRENDS RELATED TO THIS TYPE OF ISSUE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT A LEAK WAS DETECTED IN THE MINI BYPASS PUMP HEAD OF THE ECC.O OXYGENATOR DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126065 ECC.O SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM SORIN GROUP ITALIA 1601190028

    Patients

    Seq Age Sex Outcome Treatment
    1