BEUDAMED
    FDA Adverse Event Other Summary report: N

    SORIN CENTRIFUGAL PUMP 5 (CP5) CONTROL PANEL

    MDR report key: 2912930 · Received December 20, 2012

    Report

    Report Number
    1718850-2012-01105
    Event Type
    Other
    Date Received
    December 20, 2012
    Date of Event
    October 23, 2012
    Report Date
    November 28, 2012
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DWA
    PMA / PMN Number
    K112225
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER WAS NOT PROVIDED. THEREFORE, THE MFR DATE IS UNKNOWN. THE SORIN GROUP (B)(4) MANUFACTURES THE SORIN CENTRIFUGAL PUMP 5 (CP5) CONTROL PANEL. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILLED OUT ON BEHALF OF SORIN GROUP (B)(4). THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT OF A SUDDEN INCREASE IN FLOW DURING THE PROCEDURE WHICH RESULTED IN A HIGH FLOW ALARM AND SHUTTING THE AUTO CLAMP. THERE WAS NO REPORT OF PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1