BEUDAMED
    FDA Adverse Event Other Summary report: N

    CP85341 FR PARIS

    MDR report key: 2181540 · Received July 15, 2011

    Report

    Report Number
    1718850-2011-00088
    Event Type
    Other
    Date Received
    July 15, 2011
    Date of Event
    April 2, 2011
    Report Date
    June 15, 2011
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURED THIS REVOLUTION PUMPHEAD. THE 510(K) NUMBER OF THE REVOLUTION PUMPHEAD IS K030462. 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 OF A NOISE FROM THE REVOLUTION PUMPHEAD AFTER APPROXIMATELY 10 HOURS ON ECMO. THERE WAS NO REPORT OF PT INJURY. THE INVOLVED PUMPHEAD HAS BEEN RETURNED TO SORIN GROUP (B)(4) AND THEY HAVE COMPLETED THEIR INVESTIGATION. VISUAL INSPECTION OF THE RETURNED PUMPHEAD FOUND THAT THE UPPER HUB WAS DEFORMED/MELTED. DURING SIMULATED USE TESTING A SLIGHT NOISE WAS HEARD FROM THE RETURNED PUMPHEAD BUT THE PERFORMANCE WAS COMPARABLE TO THAT OF A PUMPHEAD FROM INVENTORY. ATTEMPTS TO RE-CREATE THE ISSUE ON PUMPS FROM INVENTORY WERE ONLY SUCCESSFUL AFTER RUNNING FOR AN EXTENDED PERIOD OF TIME WITH THE OUTLET LINE CLAMPED. INSPECTION OF THE PUMPHEAD AFTER TESTING REVEALED A DEFORMED UPPER HUB SIMILAR TO THAT OF THE RETURNED PUMPHEAD. THE REVOLUTION PUMPHEAD INSTRUCTIONS FOR USE STATE "DO NOT OPERATE THE PUMP FOR LONG PERIODS OF TIME WITH ITS OUTLET CLAMPED." AND "CONTROL THE BLOOD FLOW BY ADJUSTING THE PUMP SPEED. PARTIALLY CLAMPING THE OUTLET OF THE PUMP TO CONTROL THE BLOOD FLOW MAY INCREASE CELLULAR DAMAGE". BASED ON THE RESULTS OF THE INVESTIGATION, SORIN GROUP (B)(4) HAS DETERMINED THAT NO FURTHER ACTION IS NECESSARY AT THIS TIME.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT OF A NOISE FROM THE REVOLUTION PUMPHEAD AFTER APPROXIMATELY 10 HOURS ON ECMO. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CP85341 FR PARIS CUSTOM PERFUSION PACK DTZ SORIN GROUP ITALIA NA 1008170011

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR