BEUDAMED
    FDA Adverse Event Other Summary report: N

    S5 CONSOLE FOR 4 PUMP

    MDR report key: 1666427 · Received April 19, 2010

    Report

    Report Number
    1718850-2010-00021
    Event Type
    Other
    Date Received
    April 19, 2010
    Report Date
    August 10, 2007
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K071318
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE S5 CONSOLE AND THE 510(K) NUMBER IS K071318. THE INCIDENT OCCURRED AT (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. DURING THE PROCEDURE, THE LEVEL SENSOR ALARMED AND THE ARTERIAL PUMP STOPPED. THE SENSOR ALARM WAS DISABLED BUT THE PUMP ALARM REMAINED ON. AFTER RESETTING THE LEVEL CONTROL MODULE, THE PUMP STARTED. THE CLINICIAN REPORTED THAT THE TIME FOR THE PUMP TO RESTART WAS APPROXIMATELY 7.5 SECONDS. IT APPEARS BY THE REPORT DESCRIPTION THAT THE CLINICIAN FELT THE RESPONSE TIME FOR THE PUMP TO RESTART WAS TOO LONG. SORIN GROUP (B)(4) RESPONDED THAT SWITCHING THE LEVEL CONTROL MODULE OFF DISRUPTS COMMUNICATION TO THE ALLOCATED PUMP RESULTING A TIMEOUT PERIOD OF APPROXIMATELY 7.5 SECONDS. SWITCHING OFF THE LEVEL SENSOR MODULE IS NOT INTENDED TO CONTINUE PUMP OPERATION AFTER A LEVEL ALARM. IN THE EVENT OF A LEVEL ALARM, THE PUMP WILL REMAIN STOPPED UNTIL THE ALARM CONDITION HAS BEEN CORRECTED, SUCH AS RE-ESTABLISHED RESERVOIR BLOOD LEVEL OR IF THE BYPASS BUTTON IS ACTIVATED. SORIN GROUP (B)(4) STATED THE DEVICE PERFORMED AS INTENDED.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE LEVEL SENSOR ALARMED AND THE ARTERIAL PUMP STOPPED. THE SENSOR ALARM WAS DISABLED, BUT THE PUMP ALARM REMAINED ON. AFTER RESETTING THE LEVEL CONTROL MODULE, THE PUMP STARTED. THE CLINICIAN REPORTED THAT THE TIME FOR THE PUMP TO RESTART WAS APPROXIMATELY 7.5 SECONDS. THE REPORT INDICATED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S5 CONSOLE FOR 4 PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1