BEUDAMED
    FDA Adverse Event Other Summary report: N

    S3 ROLLER PUMP

    MDR report key: 3252481 · Received July 24, 2013

    Report

    Report Number
    1718850-2013-00126
    Event Type
    Other
    Date Received
    July 24, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 27, 2013
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K950990
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE S3 ROLLER PUMP. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT DURING A PROCEDURE WHEN THE CLINICIAN ATTEMPTED TO DECREASE FLOW, THE S3 ROLLER PUMP STOPPED. THE CLINICIAN WAS ABLE TO RE-ESTABLISH FLOW BY REMOVING THEIR FINGER FROM THE SPEED POTENTIOMETER. FOR THE REMAINDER OF THE CASE, THE CLINICIAN NOTED THAT TOUCHING THE SPEED POTENTIOMETER WOULD CAUSE THE PUMP TO STOP. THE CASE COMPLETED AND THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344365 S3 ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND 10-60-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NP