BEUDAMED
    FDA Adverse Event Other Summary report: N

    S3 DOUBLE HEAD PUMP

    MDR report key: 3800557 · Received May 2, 2014

    Report

    Report Number
    1718850-2014-00127
    Event Type
    Other
    Date Received
    May 2, 2014
    Date of Event
    January 4, 2014
    Report Date
    April 7, 2014
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DWB
    PMA / PMN Number
    K955038
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE S3 DOUBLE HEAD PUMP. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) REC'D A REPORT THAT THE S3 DOUBLE HEAD PUMP STOPPED W/O AN ALARM DURING A PROCEDURE DUE TO OVERPRESSURE IN THE ARTERIAL LINE. THE PUMP WAS HAND CRANKED WHEN AN ADD'L ERROR WAS DISPLAYED. THE PUMP WAS SWITCHED OUT WITH ANOTHER PUMP. THERE WAS NO REPORT OF PT INJURY. THE INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) REC'D A REPORT THAT THE S3 DOUBLE HEAD PUMP STOPPED W/O AN ALARM DURING A PROCEDURE DUE TO OVERPRESSURE IN THE ARTERIAL LINE. THE PUMP WAS HAND CRANKED WHEN AN ADD'L ERROR WAS DISPLAYED. THE PUMP WAS SWITCHED OUT WITH ANOTHER PUMP. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265300 S3 DOUBLE HEAD PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DWB SORIN GROUP DEUTSCHLAND 10-65-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR