BEUDAMED
    FDA Adverse Event Other Summary report: N

    S3 ROLLER PUMP

    MDR report key: 3031951 · Received March 27, 2013

    Report

    Report Number
    1718850-2013-00043
    Event Type
    Other
    Date Received
    March 27, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 28, 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
    FR
    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). SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE S ROLLER PUMP STOPPED AND DISPLAYED AN ERROR MESSAGE DURING THE PROCEDURE. THE CLINICIAN HAND CRANKED THE PUMP IN ORDER TO MAINTAIN BLOOD FLOW UNTIL FUNCTION WAS REGAINED BY POWER CYCLING THE PUMP. THE CASE WAS COMPLETED WITHOUT FURTHER ISSUE. THERE WAS NO REPORT OF PATIENT INJURY. 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 THE S3 ROLLER PUMP STOPPED AND DISPLAYED AN ERROR MESSAGE DURING THE PROCEDURE. THE CLINICIAN HAND CRANKED THE PUMP IN ORDER TO MAINTAIN BLOOD FLOW UNTIL FUNCTION WAS REGAINED BY POWER CYCLING THE PUMP. THE CASE WAS COMPLETED WITHOUT FURTHER ISSUE. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125665 S3 ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND 10-60-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR