BEUDAMED
    FDA Adverse Event Other Summary report: N

    S5 ROLLER PUMP

    MDR report key: 3190216 · Received June 18, 2013

    Report

    Report Number
    1718850-2013-00097
    Event Type
    Other
    Date Received
    June 18, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DWB
    PMA / PMN Number
    K071318
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. SORIN GROUP (B)(4) MANUFACTURES THE S5 ROLLER PUMP. THE INCIDENT OCCURRED IN THE (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE TOUCH SCREEN OF THE S5 ROLLER PUMP BECAME UNRESPONSIVE. THE ISSUE OCCURRED DURING SETUP. THEREFORE, 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 (B)(4) RECEIVED A REPORT THAT THE TOUCH SCREEN OF THE S5 ROLLER PUMP BECAME UNRESPONSIVE. THE ISSUE OCCURRED DURING SETUP. THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277179 S5 ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DWB SORIN GROUP DEUTSCHLAND 10-80-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA