BEUDAMED
    FDA Adverse Event Other Summary report: N

    SORIN CENTRIFUGAL PUP 5 (CP5)

    MDR report key: 3597931 · Received January 15, 2014

    Report

    Report Number
    1718850-2013-00327
    Event Type
    Other
    Date Received
    January 15, 2014
    Date of Event
    November 15, 2013
    Report Date
    December 19, 2013
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DWA
    PMA / PMN Number
    K112225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE SORIN CENTRIFUGAL PUMP 5 (CP5). 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 RAMP UP FUNCTION OF THE SORIN CENTRIFUGAL PUMP DID NOT ACTIVATE WHEN THE LEVEL ALARMED DURING A PROCEDURE. THERE WAS NO REPORT OF PT INJURY. THE INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT THE RAMP UP FUNCTION OF SORIN CENTRIFUGAL PUMP DID NOT ACTIVATE WHEN THE LEVEL ALARMED DURING A PROCEDURE. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39914 SORIN CENTRIFUGAL PUP 5 (CP5) CARDIOPULMONARY BYPASS PUMP SPEED CONTROL DWA SORIN GROUP DEUTSCHLAND 60-02-60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1