BEUDAMED
    FDA Adverse Event Summary report: N

    COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING

    MDR report key: 6001016 · Received October 5, 2016

    Report

    Report Number
    9680841-2016-00503
    Date Received
    October 5, 2016
    Date of Event
    September 7, 2016
    Report Date
    September 7, 2016
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    KFM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINED REVOLUTION PUMP (CATALOG NUMBER 436980667, LOT NUMBER 1603040080) IS A NON-STERILE DEVICE THAT WAS ASSEMBLED INTO A CONVENIENCE PACK (CATALOG 044017800, LOT 1614600031) AND STERILIZED BEFORE DISTRIBUTION AND USE IN THE USA. EXPIRATION DATE (MM/DD/YYYY) FOR CONVENIENCE PACK: 05/31/2018. (B)(4). DEVICE MANUFACTURE DATE (MM/DD/YYYY) FOR THE CONVENIENCE PACK: 05/25/2016. THE COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING WAS ASSEMBLED INTO A CONVENIENCE PACK DISTRIBUTED IN 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). (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE BLOOD FORWARD FLOW OF THE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC DECREASED DRASTICALLY 30 MINUTES INTO THE BYPASS PROCEDURE. TROUBLESHOOTING BY THE USER DID NOT SOLVE THE PROBLEM. THE CUSTOMER ELECTED TO CHANGE OUT THE ENTIRE CIRCUIT AND HEART-LUNG MACHINE TO CONTINUE THE PROCEDURE. THE CASE WAS COMPLETED WITHOUT FURTHER INCIDENT. ON SEPTEMBER 26, 2016, SORIN GROUP (B)(4) RECEIVED A USER MEDWATCH REPORT (MW5064715) REGARDING THIS EVENT. THE PERFUSIONIST REPORTED THAT IT IS BELIEVED THAT THE REVOLUTION PUMP MAY HAVE BECOME DECOUPLED DURING USE. AT THE PRESENT DATE, THIS HAS NOT BEEN CONFIRMED. ON SEPTEMBER 20, 2016, THE DEVICE WAS RETURNED TO SORIN GROUP USA FOR INVESTIGATION. VISUAL INSPECTION DID NOT IDENTIFY ANY DEFECTS OR ABNORMALITIES. THE UNIT WAS DECONTAMINATED AND RETURNED TO SORIN GROUP (B)(4) FOR FURTHER EVALUATION. THE INVESTIGATION IS IN PROGRESS. 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). ON (B)(4), 2016, THE DEVICE WAS RETURNED TO SORIN GROUP USA FOR INVESTIGATION. VISUAL INSPECTION DID NOT IDENTIFY ANY DEFECTS OR ABNORMALITIES. THE UNIT WAS DECONTAMINATED AND RETURNED TO SORIN GROUP (B)(4) FOR FURTHER EVALUATION. PERFORMANCE TESTING OF THE RETURNED REVOLUTION PUMP WAS UNABLE TO REPRODUCE ANY FLOW REDUCTION ISSUE. THE COMPLAINED DEVICE PERFORMED COMPARABLY TO ANOTHER REVOLUTION PUMP PULLED FROM THE STOCK. ACCORDING TO THE TRACEABILITY, NO OTHER COMPLAINT FOR A SIMILAR DEFECT HAS BEEN RECEIVED FOR THE COMPLAINED LOT. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY DEVIATIONS FROM THE STANDARD MANUFACTURING PROCEDURE. THE CLAIMED PUMP WAS RELEASED ACCORDING TO SPECIFICATION. AS THE ISSUE WAS NOT REPRODUCED, A ROOT CAUSE COULD NOT BE DETERMINED AND CORRECTIVE ACTIONS WERE NOT IDENTIFIED. 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 THE BLOOD FORWARD FLOW OF THE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC DECREASED DRASTICALLY 30 MINUTES INTO THE BYPASS PROCEDURE. TROUBLESHOOTING BY THE USER DID NOT SOLVE THE PROBLEM. THE CUSTOMER ELECTED TO CHANGE OUT THE ENTIRE CIRCUIT AND HEART-LUNG MACHINE TO CONTINUE THE PROCEDURE. THE CASE WAS COMPLETED WITHOUT FURTHER INCIDENT. ON SEPTEMBER 26, 2016, SORIN GROUP (B)(4) RECEIVED A USER MEDWATCH REPORT (MW5064715) REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652019 COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM SORIN GROUP ITALIA SRL 1603040080

    Patients

    Seq Age Sex Outcome Treatment
    1