BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 1484103 · Received July 22, 2009

    Report

    Report Number
    1718850-2009-00020
    Event Type
    Malfunction
    Date Received
    July 22, 2009
    Date of Event
    April 14, 2009
    Report Date
    April 20, 2009
    Manufacturer
    SORIN GROUP DEUTSCHLAND, (SORIN GROUP USA, INC. IS DISTRIBUTOR)
    Product Code
    DTQ
    PMA / PMN Number
    K950990
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B) (4) IS REQUESTING PATIENT INFORMATION FROM THE HOSPITAL. A FOLLOW-UP REPORT WILL BE FORWARDED WHEN THIS INFORMATION IS AVAILABLE. THE INCIDENT OCCURRED AT (B) (6) HOSPITAL IN (B) (6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B) (4). DURING THE PROCEDURE, THE ARTERIAL PUMP STOPPED. THERE WERE NO REPORTED ERROR CODES. THE SERVICE REPRESENTATIVE'S INVESTIGATION REVEALED NO PUMP DEFECTS. THE PUMP WAS PLACED IN THE SUCKER/VENT POSITION UNTIL A LOANER PUMP WAS DELIVERED. THE PERFUSIONIST HAND CRANKED THE PUMP PRIOR TO CHANGE OUT. THE INSTRUCTIONS FOR USE STATE TO USE HAND CRANKING TO CONTINUE OR CONCLUDE AN OPERATION AS A SOLUTION TO A PUMP STOPPAGE. UPON RECEIPT OF THE LOANER PUMP, THE PUMP IN QUESTION WAS REMOVED AND SENT TO SGI FOR FURTHER TESTING. A FOLLOW-UP REPORT WILL BE FORWARDED WHEN ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE ARTERIAL PUMP STOPPED. THE PERFUSIONIST HAND CRANKED THE PUMP. THE PUMP WAS CHANGED OUT. THERE WAS EVIDENCE FROM THE ECG THAT SOME AIR ENTERED THE CORONARY ARTERIES. THE ECG RETURNED TO NORMAL AND THE SURGERY CONTINUED WITHOUT INCIDENT. IT WAS REPORTED THAT THE PATIENT SUSTAINED SOME NEUROLOGICAL DEFICITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEART LUNG MACHINE SHOCKERT SIII PUMP DTQ SORIN GROUP DEUTSCHLAND, (SORIN GROUP USA, INC. IS DISTRIBUTOR) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1