BEUDAMED
    FDA Adverse Event Other Summary report: N

    STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS)

    MDR report key: 3780788 · Received April 17, 2014

    Report

    Report Number
    1718850-2014-00112
    Event Type
    Other
    Date Received
    April 17, 2014
    Date of Event
    March 25, 2014
    Report Date
    March 26, 2014
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DWA
    PMA / PMN Number
    K091008
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. SORIN GROUP (B)(4) MANUFACTURES THE CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS). 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 FLOW CONTROL KNOB OF THE STOCKERT CENTRIFUGAL PUMP WAS NOT RESPONDING 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 RECEIVED A REPORT THAT THE FLOW CONTROL KNOB OF THE CENTRIFUGAL PUMP WAS NOT RESPONDING DURING SET UP. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236764 STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS) CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA SORIN GROUP DEUTSCHLAND 60-01-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1