BEUDAMED
    FDA Adverse Event Death Summary report: N

    COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING

    MDR report key: 6125534 · Received November 23, 2016

    Report

    Report Number
    9680841-2016-00516
    Event Type
    Death
    Date Received
    November 23, 2016
    Date of Event
    October 6, 2016
    Report Date
    October 25, 2016
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    KFM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE REVOLUTION CENTRIFUGAL BLOOD PUMP (ITEM 436980667, LOT NUMBER 1605270048) IS A NON-STERILE DEVICE THAT WAS ASSEMBLED INTO A CONVENIENCE PACK (CATALOG 627303501, LOT 1614600056) AND STERILIZED BEFORE DISTRIBUTION AND USE IN THE USA. EXPIRATION DATE (MM/DD/YYYY) OF CONVENIENCE PACK: 05/31/2018 (B)(4). DEVICE MANUFACTURE DATE (MM/DD/YYYY) OF THE CONVENIENCE PACK: 05/25/2016. THE REVOLUTION CENTRIFUGAL BLOOD PUMP WAS ASSEMBLED INTO A CONVENIENCE PACK FOR STERILIZATION AND DISTRIBUTION IN THE USA. THE NON-STERILE REVOLUTION PUMP IS ALSO DISTRIBUTED IN THE USA (510(K) NUMBER: K030462). SORIN GROUP (B)(4) MANUFACTURES THE REVOLUTION CENTRIFUGAL BLOOD PUMP. THE INCIDENT OCCURRED IN (B)(6). (B)(4). THIS EVENT WAS INITIALLY EVALUATED AS NON-REPORTABLE. AFTERWARDS, WE RECEIVED THE INFORMATION THAT THE PATIENT DIED AND THE CUSTOMER CONFIRMED THAT THE PATIENT DEATH WAS UNRELATED TO THE REPORTED DEVICE ISSUE. THIS MEDWATCH REPORT IS BEING FILED IN RESPONSE TO THE RECEIPT OF THE USER MEDWATCH REPORT (MW5065394). THE REVOLUTION CENTRIFUGAL BLOOD PUMP WAS NOT MADE AVAILABLE FOR INVESTIGATION, AS THE DEVICE WAS DISCARDED BY THE CUSTOMER. PHOTOGRAPHIC EVIDENCE OF THE COMPLAINED DEVICE WAS PROVIDED. ANALYSIS OF THE PHOTOGRAPH IDENTIFIED CLOTTED BLOOD STAINS AND A BROKEN TOP WHITE BEARING. ACCORDING TO INITIAL REPORT, THE EVENT OCCURRED DURING ECMO. THE PATIENT SUFFERED FROM ENDOCARDITIS AND WAS ON ECMO FOR THE THIRD TIME. AN INCREASED LIKELIHOOD OF CLOTTING IS OFTEN OBSERVED DURING ECMO PROCEDURES. IT IS LIKELY THAT THE REPORTED NOISE WAS ASSOCIATED TO THE PRESENCE OF BLOOD CLOTS ACCUMULATED IN THE BOTTOM PORTION OF THE PUMP. IN THESE CASES THE PRESENCE OF BLOOD CLOTS MAY CAUSE THE ROTATING IMPELLER TO LIFT AGAINST THE WHITE BEARING, LEADING TO INCREASED FRICTION AND WEARING. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY DEVIATIONS FROM THE STANDARD MANUFACTURING PROCEDURE. THE PUMP WAS RELEASED ACCORDING TO SPECIFICATION. SORIN TRACEABILITY SHOWED THAT NO OTHER COMPLAINTS FOR SIMILAR DEFECTS HAVE BEEN RECEIVED RELATED TO THE COMPLAINED LOT. SORIN GROUP (B)(4) HAS CONCLUDED THAT THE REPORTED NOISE WAS MOST LIKELY CAUSED DUE TO THE PATIENT BLOOD CONDITIONS. HOWEVER, A CAPA INVESTIGATION HAS BEEN INITIATED TO EVALUATE THE FEASIBILITY OF MAKING DEVICE IMPROVEMENTS TO REDUCE THE PROBABILITY OF WEARING WHILE UNDER EXTREME WORKING CONDITIONS. DEVICE DISCARDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT A RATTLING NOISE FROM THE REVOLUTION CENTRIFUGAL BLOOD PUMP WAS HEARD 45 MINUTES INTO THE ECMO PROCEDURE. THE MEDICAL TEAM ELECTED TO CHANGE OUT THE DEVICE. THE CHANGE OUT OCCURRED WITH NO ISSUE. ON OCTOBER 11TH, 2016, SORIN GROUP WAS INFORMED THAT THE PATIENT PASSED AWAY ON (B)(6) 2016. FOLLOW-UP COMMUNICATION WITH THE CUSTOMER CONFIRMED THAT THE PATIENT DEATH WAS UNRELATED TO THE REVOLUTION PUMP MALFUNCTION, AS THE ISSUE WAS QUICKLY DIAGNOSED AND THE DEVICE WAS REPLACED. ON OCTOBER 25TH, 2016, SORIN GROUP (B)(4) RECEIVED A USER MEDWATCH REPORT (MW5065394) FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775891 COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM SORIN GROUP ITALIA SRL 1605270048

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death