BEUDAMED
    FDA Adverse Event Other Summary report: N

    S5 ROLLER PUMP

    MDR report key: 2944104 · Received January 30, 2013

    Report

    Report Number
    1718850-2013-00002
    Event Type
    Other
    Date Received
    January 30, 2013
    Date of Event
    December 19, 2012
    Report Date
    January 3, 2013
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K071318
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFORMATION WAS NOT PROVIDED. SORIN GROUP (B)(4) MANUFACTURES THE S5 ROLLER PUMP. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT DURING A PROCEDURE, THE CLINICIAN OBSERVED THAT THE S5 ROLLER PUMP SLOWED DOWN. THE OCCLUSION OF THE PUMP WAS CHECKED AND THE PROCEDURE RESUMED. THE PUMP SLOWED AGAIN, STOPPED, AND DISPLAYED A ROTOR ERROR MESSAGE. THE PUMP WAS CHANGED OUT. THERE WAS NO PT INJURY. THE INVESTIGATION IS ON-GOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT DURING A PROCEDURE, THE CLINICIAN OBSERVED THAT THE S5 ROLLER PUMP SLOWED DOWN. THE OCCLUSION OF THE PUMP WAS CHECKED AND THE PROCEDURE RESUMED. THE PUMP SLOWED AGAIN, STOPPED, AND DISPLAYED A ROTOR ERROR MESSAGE. THE PUMP WAS CHANGED OUT. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40079 S5 ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND 10-80-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1