BEUDAMED
    FDA Adverse Event Other Summary report: N

    S5 MAST ROLLER PUMP

    MDR report key: 3982906 · Received July 10, 2014

    Report

    Report Number
    1718850-2014-00214
    Event Type
    Other
    Date Received
    July 10, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 13, 2014
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K062396
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE S5 MAST 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 THE PUMP COVER ALARM OF THE S5 MAST ROLLER PUMP WAS NOT FUNCTIONING PROPERLY DURING SET UP. THERE WAS NO ALARM AND THE PUMP DID NOT STOP WHEN THE PUMP COVER WAS OPENED. THERE WAS NO PATIENT INVOLVEMENT. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT THE PUMP COVER ALARM OF THE S5 MAST ROLLER PUMP WAS NOT FUNCTIONING PROPERLY DURING SET UP. THERE WAS NO ALARM AND THE PUMP DID NOT STOP WHEN THE PUMP COVER WAS OPENED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405451 S5 MAST ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND 10-88-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA