BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUKE UNIV DURHAM NC 1

    MDR report key: 2217363 · Received July 15, 2011

    Report

    Report Number
    1718850-2011-00082
    Event Type
    Other
    Date Received
    July 15, 2011
    Date of Event
    April 7, 2011
    Report Date
    June 15, 2011
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DWF
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFORMATION WAS NOT PROVIDED. SORIN GROUP (B)(4) MANUFACTURES THE CUSTOM HEART LUNG PACK. THE REVOLUTION IS A COMPONENT OF THE PACK AND IS MANUFACTURED BY SORIN GROUP (B)(4). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4)RECEIVED A REPORT OF A SQUEALING NOISE FROM THE REVOLUTION PUMP HEAD AND PUMP DRIVER, WHICH RESULTED IN LOW FLOW. THE PUMP DRIVER WAS MANUALLY CRANKED TO WEAN THE PT FROM BYPASS, THEN THE PUMP HEAD WAS RESEATED INTO THE PUMP DRIVER AND THE CASE CONTINUED. THERE WAS NO REPORT OF PT INJURY. HOWEVER, FURTHER COMMUNICATION WITH THE PERFUSIONIST REVEALED THAT SUB-OPTIMAL HAND CRANKING WAS NOT ABLE TO GENERATE SUFFICIENT FLOW FOR APPROXIMATELY 4 MINUTES BEFORE ASSISTANCE WAS PROVIDED. SORIN GROUP (B)(4) MANUFACTURED THE REVOLUTION PUMP HEAD INVOLVED IN THIS INCIDENT. THE PUMP HEAD IS A COMPONENT OF THE CUSTOMER PERFUSION PACK. THE 510(K) NUMBER OF THE REVOLUTION PUMP HEAD IS K030462. THE REVOLUTION PUMP HEAD WAS RETURNED TO SORIN GROUP (B)(4) FOR EVALUATION. NO DEFECTS OR ABNORMALITIES WERE NOTED DURING VISUAL INSPECTION. THE RETURNED UNIT WAS SET UP IN A CIRCUIT AND RUN FOR SIX HOURS WHILE LISTENING FOR ABNORMAL NOISE AND MONITORING THE FLOW RATE. THE UNIT PERFORMED AS WITHOUT ANY ISSUE. THE FLOW RATE WAS MAINTAINED AND THE PUMP HEAD DID NOT PRODUCE ABNORMAL NOISE. THE REPORT OF HEARING A SQUEALING NOISE AND NOTICING THE FLOWS DROPPING OFF COULD NOT BE REPRODUCED AND THE CAUSE FOR THE CLINICIANS CONCERN COULD NOT BE DETERMINED. NO STRUCTURAL OR PERFORMANCE DEFECTS WERE FOUND. NO FURTHER ACTION IS DEEMED NECESSARY.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT OF A SQUEALING NOISE FROM THE REVOLUTION PUMP HEAD AND PUMP DRIVER, WHICH RESULTED IN LOW FLOW. THE PUMP DRIVER WAS MANUALLY CRANKED TO WEAN THE PT FROM BYPASS, THEN THE PUMP HEAD WAS RESEATED INTO THE PUMP DRIVER AND THE CASE CONTINUED. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUKE UNIV DURHAM NC 1 CUSTOM PERFUSION PACK DWF SORIN GROUP USA, INC. NA 1103100060

    Patients

    Seq Age Sex Outcome Treatment
    1