BEUDAMED
    FDA Adverse Event Other Summary report: N

    SORIN CENTRIFUGAL PUMP 5 (CP5)

    MDR report key: 3902382 · Received June 24, 2014

    Report

    Report Number
    1718850-2014-00211
    Event Type
    Other
    Date Received
    June 24, 2014
    Date of Event
    May 14, 2014
    Report Date
    June 2, 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
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE SORIN CENTRIFUGAL PUMP. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE SORIN CENTRIFUGAL PUMP WOULD NOT ROTATE DURING SET UP. 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 SORIN CENTRIFUGAL PUMP WOULD NOT ROTATE DURING SET UP. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367975 SORIN CENTRIFUGAL PUMP 5 (CP5) CARDIOPULMONARY BYPASS PUMP SPEED CONTROL DWA SORIN GROUP DEUTSCHLAND 60-00-60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA