BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 SINGLE ROLLER PUMP

    MDR report key: 1674166 · Received April 22, 2010

    Report

    Report Number
    1718850-2010-00026
    Event Type
    Malfunction
    Date Received
    April 22, 2010
    Date of Event
    November 27, 2006
    Report Date
    November 27, 2006
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K071318
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE S5 ROLLER PUMP. THE 510(K) NUMBER IS K071318. THE INCIDENT OCCURRED AT (B)(6). THIS MEDWATCH REPORT IS BEING 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. TWENTY MINUTES INTO THE PROCEDURE, THE CLINICIAN NOTED THAT THE ARTERIAL PUMP WAS TURNING SLOWLY. THERE WAS NO ALARM AND NO REGULATION BY THE LEVEL OR BUBBLE SENSOR. THE CLINICIAN TRIED TO ACCELERATE THE PUMP BY TURNING THE SPEED KNOB AND ALSO INACTIVATING THE LEVEL SENSOR, BUT THE PROBLEM REMAINED. THE PUMP WAS HAND CRANKED TO COMPLETE THE PROCEDURE. THE PUMP WAS EVALUATED BY SORIN GROUP (B)(4). THE PUMP WAS RUN FOR 48 HOURS WITHOUT ANY PROBLEMS. THE ELECTRONIC COMPONENTS WERE INSPECTED. NO ABNORMALITIES WERE NOTED. THE PUMP WAS THEN SUBJECTED TO AN ENDURANCE TEST OF 500 HOURS UNDER VARIOUS CONDITIONS. NO PROBLEMS WERE FOUND. SORIN GROUP (B)(4) COULD NOT REPRODUCE THE PROBLEM. NO FAULT WAS FOUND WITH THE PUMP.

    Description of Event or Problem · 1

    TWENTY MINUTES INTO THE PROCEDURE, THE CLINICIAN NOTED THAT THE ARTERIAL PUMP WAS TURNING SLOWLY. THERE WAS NO ALARM AND NO REGULATION BY THE LEVEL OR BUBBLE SENSOR. THE CLINICIAN TRIED TO ACCELERATE THE PUMP BY TURNING THE SPEED KNOB AND ALSO INACTIVATING THE LEVEL SENSOR, BUT THE PROBLEM REMAINED. THE PUMP WAS HAND CRANKED TO COMPLETE THE PROCEDURE. AFTER THE PROCEDURE, THE PUMP WAS USED AS AN ASPIRATION PUMP AND THERE WERE NO PROBLEMS. THE PUMP HAS BEEN CHANGED OUT WITH ANOTHER UNIT. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S5 SINGLE ROLLER PUMP PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE DTQ SORIN GROUP DEUTSCHLAND NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1