BEUDAMED
    FDA Adverse Event Other Summary report: N

    SORIN CENTRIFUGAL PUMP 5 (CP5)

    MDR report key: 4321078 · Received December 2, 2014

    Report

    Report Number
    1718850-2014-00444
    Event Type
    Other
    Date Received
    December 2, 2014
    Date of Event
    October 31, 2014
    Report Date
    November 4, 2014
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DWA
    PMA / PMN Number
    K112225
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MFR THE SORIN CENTRIFUGAL PUMP 5 (CP5). 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 THE TOUCH SCREEN OF THE CP5 CONTROL PANEL BECAME UNRESPONSIVE DURING A PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776113 SORIN CENTRIFUGAL PUMP 5 (CP5) CARDIOPULMONARY BYPASS PUMP SPEED CONTROL DWA SORIN GROUP DEUTSCHLAND 60-02-60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NP