BEUDAMED
    FDA Adverse Event Other Summary report: N

    STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP

    MDR report key: 2935423 · Received January 24, 2013

    Report

    Report Number
    1718850-2012-01133
    Event Type
    Other
    Date Received
    January 24, 2013
    Date of Event
    December 28, 2012
    Report Date
    December 28, 2012
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DWA
    PMA / PMN Number
    K032213
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. THE MANUFACTURE DATE WILL BE PROVIDED IN THE FOLLOW-UP REPORT. SORIN GROUP (B)(4) MANUFACTURES THE SCP CONTROL PANEL. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT DURING PRIMING FOR A CASE, THE SCP CONTROL PANEL LOST POWER. THERE WAS NO PATIENT INVOLVEMENT. THE INVESTIGATION IS ON-GOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT DURING PRIMING FOR A CASE, THE SCP CONTROL PANEL LOST POWER. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34754 STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA SORIN GROUP DEUTSCHLAND 60-02 15 NA

    Patients

    Seq Age Sex Outcome Treatment
    1