BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STOCKERT CENTRIFUGAL PUMP (SCP) SYSTEM

    MDR report key: 1680158 · Received May 7, 2010

    Report

    Report Number
    1718850-2010-00039
    Event Type
    Injury
    Date Received
    May 7, 2010
    Date of Event
    July 26, 2006
    Report Date
    August 4, 2006
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DWA
    PMA / PMN Number
    K032213
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B) (4) MANUFACTURES THE SCP PUMP. THE 510(K) NUMBER IS K032213. THE INCIDENT OCCURRED IN (B) (6). THIS REPORT IS FILED ON BEHALF OF SORIN GROUP (B) (4). PLEASE NOTE THAT THIS MDR IS BEING FILED LATE DUE TO A RECENT CHANGE IN SORIN GROUP (B) (4) MEDWATCH REPORTING CRITERIA AND SUBSEQUENT REVIEW OF PAST COMPLAINTS TO THE NEW CRITERIA. DURING ECC, THE CLINICIAN NOTED AN ABNORMAL NOISE COMING FROM THE SCP PUMP. THE PUMP STOPPED A FEW SECONDS LATER. THE CLINICIAN HAND CRANKED TO MAINTAIN FLOW. THE PUMP WAS CHANGED OUT. SORIN GROUP (B) (4) EVALUATED THE SCP DRIVE UNIT. THE UNIT WAS SET-UP AND RUN FOR SEVERAL DAYS WITHOUT ANY PROBLEMS. THE REPORTED NOISE COULD NOT BE REPRODUCED. THE PUMP WAS THEN RUN UNDER VARIOUS CONDITIONS, POSITIONS AND FLOW RATES. NO PROBLEMS WERE FOUND. THE DRIVE UNIT WAS DISASSEMBLED AND VISUALLY INSPECTED. NO DAMAGE OR TRACES OF FAILURE WERE NOTED. THE CLINICIAN HAND CRANKED THE PUMP PRIOR TO CHANGE OUT. THE INSTRUCTIONS FOR USE STATE TO USE HAND CRANKING TO CONTINUE OR CONCLUDE AN OPERATION AS A SOLUTION TO A PUMP STOPPAGE. SORIN GROUP (B) (4) COULD NOT RE-CREATE THE PROBLEM. THE FACILITY FILED A VIGILANCE REPORT WITH THE (B) (4) AUTHORITY. THIS MEDWATCH REPORT IS FILED AS A RESULT OF THIS ACTION.

    Description of Event or Problem · 1

    DURING ECC, THE CLINICIAN NOTED AN ABNORMAL NOISE COMING FROM THE SCP PUMP. THE PUMP STOPPED A FEW SECONDS LATER. THE CLINICIAN HAND CRANKED TO MAINTAIN FLOW. THE PUMP WAS CHANGED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STOCKERT CENTRIFUGAL PUMP (SCP) SYSTEM CARDIOPULMONARY BYPASS SPEED CONTROL SYSTEM DWA SORIN GROUP DEUTSCHLAND NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention