BEUDAMED
    FDA Adverse Event Death Summary report: N

    LAERDAL SUCTION UNIT (LSU)

    MDR report key: 991780 · Received February 6, 2008

    Report

    Report Number
    9610483-2008-00001
    Event Type
    Death
    Date Received
    February 6, 2008
    Date of Event
    March 7, 2007
    Report Date
    January 9, 2008
    Manufacturer
    LAERDAL MEDICAL A/S
    Product Code
    BTA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED LAERDAL SUCTION UNIT (LSU) MODEL 780010 WAS NOT RETURNED TO THE MANUFACTURER (LMAS) FOR EVALUATION. IT WAS RETURNED TO THE AMBULANCE SERVICE 3/7/07 WHO REPORTED THE FOLLOWING. THE LSU WAS RETURNED WITH AN INCOMPLETE REPAIR TAG STATING "SUCTION NOT WORKING" AND INDICATING AN INCIDENT REPORT FORM HAD BEEN COMPLETED BUT IT WAS NOT RETURNED WITH THE UNIT AND AN ATTEMPT TO GET IT FAILED. THE LSU WAS INSPECTED AND TESTED PER LAERDAL RECOMMENDATIONS AND NO FAULT WAS FOUND. THE REPORTER STATES THAT THE UNITS ARE TESTED EACH NIGHT, SO IT IS REASONABLE TO EXPECT THAT THE LSU WAS ALSO FULLY FUNCTIONAL AT THE TIME OF THE INCIDENT. THE AMBULANCE SERVICE CONCLUDES THAT THE ALLEGED "FAILURE" WAS MOST LIKELY CAUSED BY USER ERROR, CAUSED BY AN OPERATIVE NOT ADEQUATELY TRAINED IN THE USE OF THIS UNIT. THEY STATE THAT DURING TRAINING ON THE USE OF THIS UNIT, IT IS CONSTANTLY EMPHASIZED THAT WHEN ATTEMPTING TO ASPIRATE LARGE ITEMS OF DEBRIS, A FINGER SWEEP IS MORE APPROPRIATE TO CLEAR AN AIRWAY OF SUCH MATTER AND THEN TO RESUME ASPIRATING FLUIDS. LMAS REPORTS THIS UNIT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND THE REUSABLE CANISTER MODEL IS COMMONLY USED BY OTHER MARKETED SUCTION UNITS. THE LSU DFU STATES THAT THE LSU MUST BE OPERATED BY APPROPRIATELY TRAINED PERSONS AND GIVES GUIDANCE AS TO CORRECTIVE ACTIONS TO BE TAKEN IN THE EVENT OF A BLOCKAGE OR OTHER SYSTEM MALFUNCTION. IN THE LAST 5 YEARS, LAERDAL MEDICAL AS HAS RECEIVED NO OTHER REPORTED PATIENT INCIDENTS OF THIS NATURE (BLOCKAGE) WITH THE LAERDAL SUCTION UNIT. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE INDICATED. THE LAERDAL SUCTION MODEL 780010 WITH REUSABLE ABBOTT CANISTER AND DISPOSABLE BAG IS NOT SOLD IN THE UNITED STATES.

    Description of Event or Problem · 1

    THE FOLLOWING INCIDENT WAS REPORTED TO LAERDAL MEDICAL LTD BY A LETTER RECEIVED 1/9/08: IN ANOTHER COUNTRY IN 2007, AN ANAESTHETIZED MALE PATIENT WAS BEING VENTILATED DURING TRANSPORT WHEN HIS ENDOTRACHEAL TUBE BECAME DISLODGED AND THE DOCTOR ON BOARD ASSISTED WITH THE PATIENT'S BREATHING. THE PATIENT VOMITED BIO MATTER AND THE DOCTOR USED THE LAERDAL SUCTION UNIT (LSU) TO CLEAR THE PATIENT'S AIRWAY, SO HE COULD INTUBATE THE PATIENT IN ORDER TO SECURE THE AIRWAY. IT WAS REPORTED THAT THE LSU BECAME BLOCKED, THE AMBULANCE TECHNICIAN INTERVENED TO FREE THE BLOCKAGE BUT THE UNIT BECAME BLOCKED AGAIN. ASPIRATION WAS ABANDONED AND THE DOCTOR CONTINUED TO VENTILATE THE PATIENT, RESULTING IN THE PATIENT'S ASPIRATING BIO MATTER INTO HIS LUNGS THAT WAS, ACCORDING TO COURT TESTIMONY, A CONTRIBUTING FACTOR IN HIS DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAERDAL SUCTION UNIT (LSU) PORTABLE SUCTION UNIT BTA LAERDAL MEDICAL A/S

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death| O