BEUDAMED
    FDA Adverse Event Other Summary report: N

    EMORY/CL/KNNSTN ATLANTA GA1

    MDR report key: 1815105 · Received August 19, 2010

    Report

    Report Number
    1718850-2010-00141
    Event Type
    Other
    Date Received
    August 19, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 21, 2010
    Manufacturer
    SORIN GROUP USA
    Product Code
    DWF
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE REVOLUTION CENTRIFUGAL PUMP HEAD. THE 510(K) NUMBER IS K030462. IT IS A COMPONENT OF THE HEART LUNG PACK MANUFACTURED BY SORIN GROUP (B)(4). THE INCIDENT OCCURRED AT (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). THE PERFUSIONIST REPORTED THAT FIVE MINUTES AFTER INITIATING BYPASS, ADEQUATE FLOW COULD NOT BE ESTABLISHED THROUGH THE OXYGENATOR. THE PERFUSIONIST HAD THE PUMP AT THE MAXIMUM FLOW RATE OF 3500 RPM. ALTHOUGH FLOW WAS RESTRICTED IN THE OXYGENATOR, THE PERFUSIONIST FELT THAT THE CENTRIFUGAL PUMP HEAD MAY HAVE CAUSED THE DECREASED FLOW. AS A PRECAUTIONARY MEASURE, THE HOSPITAL REQUESTED THAT THE EQUIPMENT BE CHECKED BY SORIN FIELD SERVICE. THE REP FOUND NO ISSUES WITH EQUIPMENT. THE CENTRIFUGAL PUMP HEAD WAS RETURNED TO SORIN GROUP (B)(4) FOR EVAL. THE OXYGENATOR AND OTHER CIRCUIT COMPONENTS WERE DISCARDED BY THE HOSPITAL. VISUAL INSPECTION OF THE CENTRIFUGAL PUMP HEAD DID NOT REVEAL ANY DEFECTS. THE UNIT WAS SUBJECTED TO FUNCTIONAL TESTING AND COMPARED TO THAT OF A CONTROL. THE TEST RESULTS WERE IDENTICAL FOR BOTH DEVICES. NO PROBLEMS WERE FOUND. NO ISSUES WERE FOUND WITH THE CENTRIFUGAL PUMP HEAD. NO OTHER CIRCUIT COMPONENTS WERE RETURNED FOR EVAL. THE CAUSE OF THE RESTRICTED FLOW CANNOT BE DETERMINED. NO FURTHER ACTION IS DEEMED NECESSARY. THERE WAS NO PT INJURY. IT WAS REPORTED THAT THE FACILITY HAD ISSUED AN INCIDENT REPORT WITH RISK MANAGEMENT. THIS MEDWATCH REPORT IS BEING FILED AS A RESULT OF THIS ACTION.

    Description of Event or Problem · 1

    THE PERFUSIONIST REPORTED THAT FIVE MINUTES AFTER INITIATING BYPASS, ADEQUATE FLOW COULD NOT BE ESTABLISHED THROUGH THE OXYGENATOR. THE PT'S HEART WAS STILL BEATING. THE PROCEDURE WAS TERMINATED AND THE ENTIRE CIRCUIT WAS CHANGED OUT. THE PROCEDURE CONTINUED WITHOUT ANY PROBLEMS. THERE WERE NO PT ISSUES AS A RESULT OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMORY/CL/KNNSTN ATLANTA GA1 CUSTOM HEART LUNG PACK DWF SORIN GROUP USA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1