BEUDAMED
    FDA Adverse Event Other Summary report: N

    SENSORMEDICS

    MDR report key: 1398854 · Received June 3, 2009

    Report

    Report Number
    2021710-2009-00017
    Event Type
    Other
    Date Received
    June 3, 2009
    Date of Event
    May 6, 2009
    Report Date
    June 3, 2009
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    BTY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARDINAL HEALTH POST MARKET QUALITY ASSURANCE DEPT. SENT A LETTER TO THE USER FACILITY SEEKING ADDITIONAL INFO CONCERNING THE REPORTED EVENT AND THE STATUS OF THE PT. AS OF THE DATE OF THIS REPORT THE USER FACILITY HAS NOT RESPONDED TO THAT LETTER. THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MANUFACTURE. EVENT CODES WERE DERIVED BASED ON INFO DOCUMENTED BY A CARDINAL HEALTH SALES CONSULTANT IN RESPONSE TO CONVERSATION WITH THE USER FACILITY (B) (6) DIRECTOR. (B) (4): THE FOLLOWING INFO CONCERNING THE EVALUATION OF THE DEVICE AND EVENT IS A SUMMARY OF THE INFO DOCUMENTED BY THE CARDINAL HEALTH SALES CONSULTANT AFTER SPEAKING WITH THE USER FACILITY (B) (6) DIRECTOR. PER THE USER FACILITY (B) (6) DIRECTOR, THEY ARE TESTING PATIENTS USING A 3RD PARTY PULMONARY FUNCTION TEST FILTER (PULMOGUARD FILTERS FROM (B) (6)). CARDINAL HEALTH RECOMMENDS THE USER OF THE MICROGARD FILTER WHICH IS A SINGLE USE DEVICE.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CARDINAL HEALTH SALES CONSULTANT IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REPRESENTATIVE. "I RECEIVED A CALL THIS MORNING FOR THE DIRECTOR OF (B) (6) AT (B) (6) HOSPITAL IN (B) (6). A PT HAS TOLD THE HOSPITAL THAT THEY RECEIVED A LUNG INFECTION FROM THE PFT MACHINE." THE FOLLOWING INFO IS A SUMMARY OF AN EMAIL DOCUMENTED BY THE CARDINAL HEALTH SALES CONSULTANT AFTER SPEAKING WITH THE USER FACILITY (B) (6) DIRECTOR. THE USER FACILITY WAS TESTING PATIENTS USING PULMOGUARD FILTERS FROM (B) (6), THE CUSTOMER HAS CONTACTED (B) (6) FOR THE NECESSARY DOCUMENTATION ON THEIR FILTERS. THE USER FACILITY WILL NOT BE PERFORMING ANY TYPE OF CULTURE TEST ON THE SYSTEM. THE PATIENT'S INFECTION WAS NOTED 8 DAYS AFTER HER PULMONARY TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSORMEDICS 73BTY CALCULATOR, PREDICTED VALVES, PUL FU BTY CARDINAL HEALTH 207, INC. VMAX ENCORE 22D

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK "PULMOGUARD FILTER FROM QUESET MEDICAL."