BEUDAMED
    FDA Adverse Event Other Summary report: N

    C20880 AD./ECMO PTS

    MDR report key: 1659080 · Received April 6, 2010

    Report

    Report Number
    1718850-2010-00085
    Event Type
    Other
    Date Received
    April 6, 2010
    Date of Event
    January 26, 2010
    Report Date
    March 14, 2010
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DWE
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED AT (B)(6) IN (B)(6). (B)(4). THE PUMP WAS RETURNED TO SORIN GROUP (B)(4) FOR EVAL. VISUAL INSPECTION REVEALED THAT THE UPPER WHITE BEARING WAS DAMAGED AND THE BEARING PLASTIC MATERIAL WAS MELTED ON THE SPINDLE. THE BEARING SURFACE RESIN WAS NOT TRANSPARENT, BUT SHOWED A WHITE RING WITH BLACKENED MATERIAL IN THE CENTER. SEVERAL IMPELLER SHAFTS WERE DAMAGED AND THERE WERE ABRASIONS ON THE HOUSING SURFACE WHERE POSSIBLE IMPELLER CONTACT OCCURRED. A BLOOD CLOT WAS FOUND ON THE LOWER PORTION OF THE IMPELLER, NEAR THE RED BEARING. LABORATORY TESTING CONFIRMED THE NOISE GENERATED BY THE PUMP. AT 3000 RPM, THE IMPELLERS DID GRAZE THE INNER SURFACE OF THE HOUSING AND THE SPINDLE PIERCED THE UPPER SURFACE OF THE BEARING. IN AN IN VITRO EXPERIMENT, THE NOISE, DECREASED FLOW AND DAMAGE WERE REPRODUCED WHEN CLOT FORMATION WAS INDUCED USING BOVINE BLOOD. SORIN GROUP (B)(4) CONCLUDED THAT IF SEVERE CLOTTING OCCURRED, IT MAY AFFECT THE FUNCTIONALITY OF THE PUMP, EVENTUALLY DAMAGING IT. ARTIFICIALLY DEFECTIVE UNITS SIMILAR TO THE DEFECTIVE UNIT WERE BUILT, SUBJECTED TO FUNCTIONAL TESTING, AND INSPECTED FOR NOISE AND DECREASED FLOW OVER 8 HOURS. NO NOISE OR FLOW REDUCTION WAS OBSERVED. THE INSTRUCTIONS FOR USE STATE "THE S5 SYSTEM HAS BEEN QUALIFIED ONLY FOR DURATIONS APPROPRIATE TO CARDIOPULMONARY BYPASS PROCEDURES AND HAS NOT BEEN QUALIFIED, THROUGH IN VITRO, IN VIVO, OR CLINICAL STUDIES, FOR LONG TERM USE AS A BRIDGE TO TRANSPLANT, PENDING RECOVERY OF THE NATURAL HEART, OR EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) PROCEDURES". BASED ON THE ANALYSIS, SORIN GROUP (B)(4) CONCLUDED THAT THE PROBLEM WAS NOT RELATED TO A MFG OR DEVICE MALFUNCTION. NO FURTHER ACTION IS DEEMED NECESSARY.

    Description of Event or Problem · 1

    DURING PRIME, THERE WERE FLOW PROBLEMS NOTED WITH THE CENTRIFUGAL PUMP. DUE TO THE URGENCY OF THE CASE (THE PT HAD INSUFFICIENT CARDIAC OUTPUT), THE CLINICIAN ELECTED TO USE THE CENTRIFUGAL PUMP AND PROCEEDED TO PLACE THE PT ON ECMO. DURING THE PROCEDURE, THE FLOW DID NOT EXCEED 4 LITERS/MINUTE. AFTER TWO TO THREE HOURS, THE PUMPHEAD STARTED TO MAKE NOISE AND VIBRATE. THE CLINICIAN REPLACED THE CENTRIFUGAL PUMP AND FLOW WAS RESTORED TO 4.5 LITERS/MINUTE. THERE WAS A REPORT THAT CARDIAC MASSAGE WAS PERFORMED. HOWEVER, ATTEMPTS TO DETERMINE IF THIS WAS DONE AS A RESULT OF THE INCIDENT OR WAS DUE TO THE PT'S CONDITION HAVE BEEN UNSUCCESSFUL. THE REPORT DID STATE THAT THE PT RECOVERED AND IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C20880 AD./ECMO PTS PERFUSION TUBING SYSTEM DWE SORIN GROUP ITALIA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1