BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSORMEDICS

    MDR report key: 1163094 · Received September 16, 2008

    Report

    Report Number
    2021710-2008-00079
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    August 17, 2008
    Report Date
    September 15, 2008
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    LSZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING INFO CONCERNING THE EVAL PERFORMED BY THE USER FACILITY WAS DERIVED BY THE INFO DOCUMENTED BY THE CARDINAL HLTH TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REP, AND FROM AN E-MAIL FROM THE USER FACILITY'S RESPONSE TO A LETTER SENT BY CARDINAL HLTH SEEKING ADD'L INFO. THE USER FACILITY'S RESP THERAPY SVS MGR EVALUATED THE DEVICE AND IDENTIFIED THAT THE OXYGEN GAS LINE COMING FROM THE WALL SUPPLIED O2 SOURCE WAS CONNECTED TO THE AIR/O2 BLENDER AUXILIARY PORT AND NOT TO THE AIR/O2 BLENDER INPUT PORT RESULTING IN DELIVERY OF 100% O2. THE USER FACILITY'S RESP THERAPY SVS MGR CONNECTED THE AIR/O2 BLENDER HOSES TO THE CORRECT CONFIGURATION AS STATED IN THE USER MANUAL. ONCE THE AIR/O2 BLENDER HOSES WERE CONFIGURED CORRECTLY, THE DEVICE DELIVERED ACCURATE OXYGEN CONCENTRATION. AT PRESENT, THE DEVICE WAS RELEASED FOR IN SVS OPERATION.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CARDINAL HLTH TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REP. "[NAME REMOVED] CALLED TO REPORT THAT THIS VENT HAS BEEN ON A PT FOR OVER A WEEK WHEN IT WAS NOTICED THAT 100% O2 WAS BEING DELIVERED ALL THAT TIME. THEY WERE MADE AWARE TO THIS ONLY WHEN "INHALED NITRIC OXIDE" WAS SET UP AND THE O2 ANALYZER READ <98%. THEY DID NOT HAVE AN EXTERNAL ANALYZER IN-LINE PRIOR TO INO THERAPY. AFTER INVESTIGATING, THEY FOUND THAT THE BLENDER WAS HOOKED UP WRONG (OXYGEN GAS LINE FROM WALL WAS CONNECTED TO THE AUXILLIARY PORT, NOT THE INLET TO THE BLENDER). [NAME REMOVED] REPORTS THAT THE BLENDER WAS HOOKED UP THIS WAY BY OUR FIELD SVC REP [NAME REMOVED] AT INSTALLATION. SHE REPORTS THAT THEIR OTHER DEVICE WAS FOUND HOOKED UP THE SAME WAY. ALL IS WELL NOW WITH BOTH VENTS; THE BLENDER CONFIGURATION WAS CORRECTED. SHE DOESN'T KNOW WHAT HARM THIS WILL HAVE ON THIS PREMATURE INFANT, BUT BEING ON AN FIO2 OF 100% FOR OVER A WEEK IS "NOT GOOD". I EXPLAINED TO HER THAT OUR INSTALL INCLUDES THE PT CIRCUIT CALIBRATION AND PERFORMANCE CHECK TO ENSURE THAT THE VENTILATOR PERFORMS TO SPECS. AS STATED IN THE OPERATOR'S MANUAL, AN EXTERNAL O2 MONITORING DEVICE SHOULD BE USED TO ENSURE ACCURATE O2 DELIVERY. SHE UNDERSTOOD, BUT SAID THAT THE FIELD REP SHOULD KNOW HOW TO SET UP THE BLENDER. I AGREED. I TOLD HER THAT I DOCUMENT THIS COMPLAINT IN OUR COMPLAINT SYSTEM. SHE REQUESTS A F/U FROM QA VIA EMAIL (DURING MY DOCUMENTATION, IT WAS DISCOVERED THAT THE INSTALLATION WAS 2007, NOT A FEW WEEKS AGO LIKE SHE HAD ME BELIEVE)". THE FOLLOWING ADD'L INFO CONCERNING THE EVENT WAS COPIED FROM AN EMAIL REC'D FROM THE USER FACILITY ON 09/02/08, IN RESPONSE TO AN EMAIL SENT BY CARDINAL HLTH SEEKING ADD'L INFO. "ON THE PREVIOUS MONTH, THE PHYSICIAN ORDERED A SPECIALTY GAS CALLED NITRIC OXIDE THAT IS DELIVERED BY INHALATION THROUGH THE VENTILATOR, THE NITRIC OXIDE SYS HAS A BUILT IN ANALYZER TO ANALYZE DELIVERED AMOUNTS OF NITRIC OXIDE, NITROGEN DIOXIDE AND OXYGEN CONCENTRATION THAT IS GOING TO THE PT. WITH THE OSCILLATOR OXYGEN BLENDER SET AT 21%, THE ANALYZER WAS READING 96%, UNSURE OF THE DISCREPANCY THE THERAPISTS CHARTED THE SET OXYGEN & THE ANALYZED OXYGEN. I WAS CONTACTED THE MORNING OF THE NEXT DAY, FOR GUIDANCE AND TROUBLESHOOTING. I, MGR RESP THERAPY SVS, INFORMED THE THERAPIST THAT I WAS ON MY WAY TO WORK & WE WILL NEED TO VERIFY BY PERFORMING AN EXTENDED CALIBRATION OF THE SENSORS OF THE NITRIC OXIDE SYS AND CONTINUE TO TROUBLESHOOT IF THE PROBLEM PERSISTS. A SECOND NITRIC OXIDE SYS WAS BROUGHT TO THE BEDSIDE AFTER AN EXTENDED CALIBRATION HAD BEEN PERFORMED, SO I, MGR RESP THERAPY SVS, WAS ABLE TO VISUALIZE AND VERIFY THE PASSING OF THE OXYGEN SENSOR ACCURACY. THE SECOND SYS WAS TRADED OUT WITH THE ONE THAT WAS IN-LINE WITH THE OSCILLATOR WHILE ON THE PT. IMMEDIATELY THE SECOND ANALYZER WAS READING A HIGH AMOUNT OF OXYGEN WITHIN THE SYS VERIFYING THAT THE ANALYZER WAS WORKING CORRECTLY. A THIRD ANALYZER WAS PLACED IN LINE WITH THE OSCILLATOR ON THE INSPIRATORY TUBING PROXIMAL TO THE HUMIDIFIER INLET TO VERIFY THE ACCURACY BETWEEN THE ANALYZER PROXIMAL TO THE PT, BOTH ANALYZERS WERE READING HIGH FIO2'S. THIS CONFIRMED THE PROBLEM WAS WITHIN THE BLENDER AND UPON INVESTIGATION OF THE BLENDER ASSEMBLY, IT WAS OBVIOUSLY ASSEMBLED INCORRECTLY. A DECISION WAS MADE TO SWITCH THE ASSEMBLED HOSES ON THE BLENDER TO ACCURATELY TO PROVIDE THE LOWEST AMOUNT OF OXYGEN REQUIRED BY THE PT TO KEEP HIS OXYGEN SATURATIONS <95% AS THE HIGH OXYGEN CAN BE HARMFUL TO THE PT'S RETINAL VESSELS CAUSING THEM TO CONSTRICT WHICH CAN LEAD TO NECROSIS (DEATH) OF THE VESSELS. THE BLENDER DID NOT ALARM, WILL ONLY ALARM WHEN SOURCE GAS IS INSUFFICIENT. THE PT CONTINUED TO BE VENTILATED ON THE 3100 A HFOV WITH THE ANALYZER ON THE INO VENTILATOR ACCURATELY MEASURING THE SET BLENDED PERCENTAGE OF OXYGEN. THE PT WAS DISCONTINUED FROM HFOV ON TWO DAYS LATER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSORMEDICS HIGH FREQUENCY OSCILLATORY VENT LSZ CARDINAL HEALTH 207, INC. 3100A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PULSE OXIMETER -GE| INO VENT - IKARIA| VIA LVM- INTERNATIONAL BIOMEDICAL| HUMIDIFIER - HUDSON| IV-PUMPS - MEDEX| ECG LEADS - GE| GIRAFFE ONMIBED - GE