BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR, LOW LEVEL II

    MDR report key: 1665258 · Received April 16, 2010

    Report

    Report Number
    1718850-2010-00022
    Event Type
    Malfunction
    Date Received
    April 16, 2010
    Date of Event
    April 6, 2006
    Report Date
    April 10, 2006
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K950990
    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 LOW LEVEL SENSOR. THE SENSOR IS A COMPONENT OF THE S3 ROLLER PUMP CONSOLE, 510(K) NUMBER K950990. THE INCIDENT OCCURRED AT (B) (6) 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 DEUTSCHLAND'S MEDWATCH REPORTING CRITERIA AND SUBSEQUENT REVIEW OF THE PAST COMPLAINTS TO THE NEW CRITERIA. SORIN GROUP (B) (4) RECEIVED THE LEVEL SENSOR AND SENT IT TO AN EXTERNAL LABORATORY FOR FURTHER EVAL. VISUAL INSPECTION WITH STEREOMICROSCOPE REVEALED THAT THE STRAIN RELIEF ON THE CONNECTING CABLE WAS BROKEN AND EXTERNALLY DAMAGED. AUTOPSY SHOWED THAT THE CONNECTING WIRE WAS DISCONNECTED FROM THE SOLDERING JOINT. WITH MECHANICAL LOAD (TENSILE LOADING AND VIBRATIONS) AND TEMPERATURE DIFFERENCE, THE ELECTRICAL CONTACT OF THIS WIRE CAN BE INTERRUPTED AND CAN LEAD TO THE INTERMITTENT FAILURE OF THE SENSOR. THE LABORATORY CONCLUDED THAT MECHANICAL LOAD OVER THE DEFECTIVE STRAIN RELIEF LED TO THE LOOSENING OF THE CONNECTION CABLE. HOW THE STRAIN RELIEF MECHANISM BECAME DAMAGED. SORIN GROUP (B) (4) STATED THAT, AS A SAFETY FACTOR, IF A SENSOR FAILS, THE SYSTEM CAN COMPENSATE FOR THE FAILURE. IN THIS CASE, THE FAILURE OF THE LEVEL SENSOR IS COMPENSATED BY THE BUBBLE SENSOR.

    Description of Event or Problem · 1

    PRIOR TO USE, THE LEVEL SENSOR WAS CHECKED WITH NO ISSUES FOUND. DURING ECC, THE BLOOD LEVEL DROPPED BELOW THE SENSOR. THE ARTERIAL PUMP DID NOT STOP AND THERE WAS NO ALARM. THE CLINICIAN NOTED THAT THE SENSOR CABLE WAS DAMAGED. ONCE REPLACED, THE PROBLEM WAS RESOLVED. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSOR, LOW LEVEL II LEVEL SENSOR DTQ SORIN GROUP DEUTSCHLAND NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1