BEUDAMED
    FDA Adverse Event Other Summary report: N

    SCP CONTROL PANEL

    MDR report key: 2414900 · Received January 5, 2012

    Report

    Report Number
    1718850-2011-00281
    Event Type
    Other
    Date Received
    January 5, 2012
    Date of Event
    May 21, 2010
    Report Date
    August 26, 2011
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K032213
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE SCP CONTROL PANEL. THE SCP CONTROL PANEL IS A COMPONENT OF THE SCP UNIT W/ FAST CLAMP CON WHICH WAS CLEARED UNDER 510(K) K032213. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). PLEASE NOTE THAT THIS MDR IS BEING FILED LATE DUE TO A RECENT CHANGE IN SORIN GROUP (B)(4) MEDWATCH REPORTING CRITERIA AND SUBSEQUENT REVIEW OF PAST COMPLAINTS TO THE NEW CRITERIA. SORIN GROUP (B)(4) REC'D A REPORT THAT THE SCP PUMP STOPPED AND THE DISPLAY WENT DARK AT THE END OF BYPASS, BUT BEFORE THE RESERVOIR WAS EMPTIED. AFTER RESTARTING THE PUMP, AN ERROR MESSAGE WAS DISPLAYED. THERE WAS NO REPORT OF PT INJURY. A SORIN FIELD SERVICE REP WENT TO THE FACILITY AND REPLACED THE CONTROL PANEL WITH A LOANER. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A F/U REPORT.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) REC'D A REPORT THAT THE SCP PUMP STOPPED AND THE DISPLAY WENT DARK AT THE END OF BYPASS. AFTER RESTARTING THE PUMP, AN ERROR MESSAGE WAS DISPLAYED. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCP CONTROL PANEL PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE DTQ SORIN GROUP DEUTSCHLAND 60-02-15 NA

    Patients

    Seq Age Sex Outcome Treatment
    1