BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENSORMEDICS

    MDR report key: 1231095 · Received November 14, 2008

    Report

    Report Number
    2021710-2008-00107
    Event Type
    Death
    Date Received
    November 14, 2008
    Date of Event
    September 8, 2008
    Report Date
    November 14, 2008
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    LSZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CARDINAL HEALTH SENT A LETTER TO THE USER FACILITY SEEKING ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT AND STATUS OF THE PATIENT. THE USER FACILITY RESPONDED THAT THE PATIENT HAD EXPIRED IN 2008. ON 10/21/2008, CARDINAL HEALTH SENT A SECOND LETTER VIA FAX TO THE USER FACILITY SEEKING ADDITIONAL INFORMATION CONCERNING THE REPORTED PATIENT EXPIRATION. AS OF THE DATE OF THIS REPORT, THERE HAS BEEN NO RESPONSE FROM THE USER FACILITY. THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MANUFACTURER. EVENT CODES WERE DERIVED BASED ON INFORMATION DOCUMENTED BY A CARDINAL HEALTH TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REPRESENTATIVE AND A LETTER RECEIVED ON 10/17/2008 FROM THE USER FACILITY THAT WAS IN RESPONSE TO A LETTER SENT BY CARDINAL HEALTH SEEKING ADDITIONAL INFORMATION. THE FOLLOWING INFORMATION CONCERNING THE EVALUATION OF THE DEVICE IS A SUMMARY OF THE INFORMATION DOCUMENTED BY A CARDINAL HEALTH TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A (THIRD PARTY SERVICE COMPANY) REPRESENTATIVE. THE (THIRD PARTY SERVICE COMPANY) SERVICE TECH EVALUATED THE DEVICE AND WAS ABLE TO VERIFY THE COMPLAINT. THE SERVICE TECH IDENTIFIED THAT THE AIRWAY PRESSURE LUER FITTING WAS LOOSE CAUSING THE MAP AND AMP TO FLUCTUATE AS THE ROOT CAUSE OF THE REPORTED FAILURE. THE (THIRD PARTY SERVICE COMPANY) SERVICE TECH TIGHTENED THE LOOSE AIRWAY PRESSURE LUER FITTING AND RAN THE DEVICE THROUGH A COMPLETE CALIBRATION AND CHECKOUT (SPI) TO ENSURE THAT IT MEETS ALL FACTORY SPECIFICATIONS. A ROOT CAUSE FOR THE REPORTED LOOSE AIRWAY PRESSURE LUER FITTING COULD NOT BE IDENTIFIED. THE AIRWAY PRESSURE LUER FITTING COULD HAVE BECOME LOOSE DURING THE INITIAL PATIENT SETUP OR DURING TRANSIT FROM THE RENTAL FACILITY TO THE USER FACILITY. UPON COMPLETION, THE UNIT WAS RETURNED TO THE RENTAL POOL READY TO BE PLACED BACK INTO RENTAL SERVICE.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CARDINAL HEALTH TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REPRESENTATIVE IN 2008. "[NAME REMOVED] CALLED TO REPORT ISSUES WITH THIS RENTAL UNIT. IT WAS ON A PATIENT AND THE DELTA P WOULD DROP BY APPROX 20 FROM 36 TO 20 AND MAP ADJUST KNOB WAS NOT ADJUSTING THE MAP AS IT SHOULD. THE PATIENT WAS REMOVED FROM THE VENT AND PLACED ON ANOTHER UNIT. AFTER THE PATIENT WAS TAKEN OFF OF THE UNIT, IT WAS NOTED THAT THE AIRWAY SENSE LUER LOCK WAS LOOSE. WILL AUTHORIZE A REPLACEMENT WITH RENTALS." THE FOLLOWING EVENT DESCRIPTION WAS COPIED FROM A LETTER RECEIVED ON 10/17/2008 FROM THE USER FACILITY THAT WAS IN RESPONSE TO A LETTER SENT BY CARDINAL HEALTH SEEKING ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT AND STATUS OF THE PATIENT. "IN 2008, PT. WAS SET UP ON 3100A RENTAL 0615 MAP 10, H2 12, AMPS 18, 100% FI02. AT 0715 RT NOTICED MAPS WERE INCONSISTENT WITH WHAT WAS DIALED IN ALONG WITH AMPLITUDE. THE 3100A CHANGED OUT AT 0720. NO OTHER PROBLEMS OCCURRED." "ON SAME DAY, PT - STILL REQUIRED HFO AND CHANGED TO ANOTHER 3100A." "PT EXPIRED THE NEXT DAY 1555. DX: EXTREME PREMATURITY. ELECTROLYTES UNSTABLE GRADE 4 BILAT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSORMEDICS 73LSZ VENTILATOR, HIGH FREQUENCY LSZ CARDINAL HEALTH 207, INC. 3100A

    Patients

    Seq Age Sex Outcome Treatment
    1 1.5 DA Death HUDSON CONCHA 4