BEUDAMED
    FDA Adverse Event Death Summary report: N

    COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING

    MDR report key: 6004121 · Received October 6, 2016

    Report

    Report Number
    9680841-2016-00505
    Event Type
    Death
    Date Received
    October 6, 2016
    Date of Event
    September 9, 2016
    Report Date
    September 9, 2016
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    KFM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF DEATH IS UNKNOWN. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF AND WHEN MADE AVAILABLE. TWO SORIN GROUP (B)(4) REVOLUTION DISPOSABLE PUMPS OF THE SAME LOT (1604280095) WERE USED DURING THE PROCEDURE. BOTH DISPOSABLES WERE NON-STERILE DEVICES ASSEMBLED INTO TWO CONVENIENCE PACKS OF THE SAME CATALOG AND LOT NUMBER (CATALOG 627352201, LOT 1619600061) AND STERILIZED BEFORE DISTRIBUTION AND USE IN THE USA. EXPIRATION DATE (MM/DD/YYYY) FOR THE CONVENIENCE PACK LOT 1619600061: 07/31/2018. UNIQUE IDENTIFIER (UDI) NUMBER FOR THE CONVENIENCE PACK LOT 1619600061: ((B)(4). DEVICE MANUFACTURE DATE (MM/DD/YYYY) FOR THE CONVENIENCE PACK LOT 1619600061: 07/14/2016. THE COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING WAS A NON-STERILE DEVICE ASSEMBLED INTO A CONVENIENCE PACK FOR STERILIZATION AND DISTRIBUTION IN THE USA. THE NON-STERILE PUMP IS SIMILAR TO THE DISPOSABLE ITEM 050300700, WHICH IS DISTRIBUTED IN THE USA AS A STERILE DEVICE (510(K)NUMBER: K030462). SORIN GROUP (B)(4) MANUFACTURES THE COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE BLOOD FLOW OF THE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING DECREASED AND WENT TO NEARLY ZERO DURING AN ECMO PROCEDURE. THE CLINICIAN ELECTED TO CHANGE-OUT THE ENTIRE HEART-LUNG MACHINE AND THE CIRCUIT. BLOOD FLOW WAS REESTABLISHED, HOWEVER LATER IN THE PROCEDURE, THE FLOW WENT DROPPED NEARLY TO ZERO AGAIN. THE CENTRIFUGAL SUPPORT DEVICE AND CIRCUIT WERE SWITCHED OUT WITH NON-SORIN DEVICES. THE CUSTOMER REPORTED THAT THE PATIENT WAS HYPERCOAGULABLE AND EXPERIENCED DEEP VEIN THROMBOSES AND PULMONARY EMBOLI. THE CUSTOMER REPORTED THAT CLOTS WERE VISIBLE INSIDE THE SORIN DEVICES. THROUGH FOLLOW-UP COMMUNICATION WITH THE CUSTOMER, SORIN GROUP (B)(4) HAS BEEN INFORMED THAT THE PATIENT EXPIRED SEVERAL DAYS AFTER THE EVENT. THE TWO DEVICES HAVE BEEN RETURNED TO SORIN GROUP (B)(4) FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). TWO REVOLUTION PUMPS FROM THE SAME LOT WERE RETURNED TO SORIN GROUP (B)(4) FOR INVESTIGATION. VISUAL INSPECTION OF THE UNITS IDENTIFIED CLOTTED BLOOD STAINS AND REVEALED THAT THE TOP WHITE BEARING OF BOTH UNITS WAS BROKEN. IN ONE OF THE RETURNED PUMPS, THE RESINS ABOVE THE TOP WHITE BEARING APPEARED MELTED AND DEFORMED. IN THE OTHER PUMP, CLOTTED BLOOD STAINS WERE ALSO IDENTIFIED BELOW THE BOTTOM RED BEARING. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY DEVIATIONS FROM THE STANDARD MANUFACTURING PROCEDURE. THE IN PROCESS SPIN TEST WAS SUCCESSFULLY PASSED BY BOTH UNITS AND THE DEVICES WERE RELEASED ACCORDING TO SPECIFICATION. ACCORDING TO THE DEVICE TRACEABILITY, NO OTHER COMPLAINTS FOR SIMILAR DEFECTS HAVE BEEN RECEIVED RELATED TO THE COMPLAINED LOT. AS BOTH UNITS WERE RETURNED WITH THE WHITE TOP BEARING SEVERELY DAMAGED, IT WAS NOT POSSIBLE TO PERFORM FUNCTIONAL TESTING, AS A SEVERELY DAMAGE TOP BEARING CAUSES THE PUMP TO RUN ABNORMALLY AND IMPAIRS ANY FUNCTIONAL CHARACTERIZATION. ACCORDING TO INFORMATION, THE EVENT OCCURRED IN ECMO, THE PATIENT WAS HYPERCOAGULABLE AND EXPIRED SEVERAL DAYS AFTER THE DESCRIBED ISSUE. SORIN GROUP (B)(4) HAS CONCLUDED THAT THE MOST PROBABLE ROOT CAUSE OF THE REPORTED FLOW PROBLEM IS ASSOCIATED WITH CLOTTING PHENOMENON TRIGGERED BY THE CONDITIONS OF THE PATIENT. ACCUMULATION OF BLOOD CLOTS IN THE BOTTOM PART OF THE PUMP CAN CAUSE THE ROTATING IMPELLER TO LIFT AND PRESS AGAINST THE WHITE BEARING LEADING TO INCREASED FRICTION AND OVERHEATING OF THE REVOLUTION TOP. THOUGH IT WAS DETERMINED THAT THE REPORTED ISSUE WAS LIKELY ASCRIBABLE TO SPECIFIC CHALLENGING USE CONDITIONS RATHER THAN A DEVICE FAILURE, SORIN GROUP (B)(4) HAS INITIATED A CAPA PROCESS TO IDENTITY ACTIONS TO REDUCE THE POSSIBILITY FOR THE TOP WHITE BEARING TO WEAR DURING USE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE BLOOD FLOW OF THE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING DECREASED AND WENT TO NEARLY ZERO DURING AN ECMO PROCEDURE. THE CLINICIAN ELECTED TO CHANGE-OUT THE ENTIRE HEART-LUNG MACHINE AND THE CIRCUIT. BLOOD FLOW WAS REESTABLISHED, HOWEVER LATER IN THE PROCEDURE, THE FLOW WENT NEARLY TO ZERO AGAIN. THE CENTRIFUGAL SUPPORT DEVICE AND CIRCUIT WERE SWITCHED OUT WITH NON-SORIN DEVICES. THE CUSTOMER REPORTED THAT THE PATIENT WAS HYPERCOAGULABLE AND EXPERIENCED DEEP VEIN THROMBOSES AND PULMONARY EMBOLI. THE CUSTOMER REPORTED THAT CLOTS WERE VISIBLE INSIDE THE SORIN DEVICES. THROUGH FOLLOW-UP COMMUNICATION WITH THE CUSTOMER, SORIN GROUP (B)(4) HAS BEEN INFORMED THAT THE PATIENT EXPIRED SEVERAL DAYS AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661161 COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM SORIN GROUP ITALIA SRL 1604280095

    Patients

    Seq Age Sex Outcome Treatment
    1 Death