BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 1518484 · Received October 13, 2009

    Report

    Report Number
    2021710-2009-00038
    Event Type
    Malfunction
    Date Received
    October 13, 2009
    Date of Event
    September 10, 2009
    Report Date
    October 13, 2009
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    CAI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CAREFUSION FAILURE ANALYSIS LAB TECHNICIAN EVALUATED ONE 3100B FILTERED PATIENT CIRCUIT RETURNED BY THE USER FACILITY AND WAS ABLE TO VERIFY THE REPORTED EVENT. IN ADDITION, A CAREFUSION MECHANICAL ENGINEER EVALUATED A SAMPLE CIRCUIT FROM THE SAME LOT CODE AND DETERMINED THAT THE CONTACT AREA ON THE EXTERNAL VALVE BODY CIRCUIT TO VALVE BODY INDICATES 90% SIGNS OF WETTING SURFACE. AN INTERNAL CORRECTIVE ACTION REQUEST (CAR) WAS INITIATED TO ADDRESS THIS ISSUE. THE USER FACILITY WAS SHIPPED REPLACEMENT 3100B FILTERED PATIENT CIRCUITS.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO PHONE CONVERSATION WITH A USER FACILITY REPRESENTATIVE. THE CUSTOMER CALLED COMPLAINING ABOUT PT CIRCUIT (B)(4) HE NOTED CONTROL VALVE ASSY HAS COME OFF THE CIRCUIT, HE NOTED THIS ON 2 CIRCUITS TO LOT#/SO# PROVIDED, NO PT ISSUES NOTED BY [NAME REMOVED]. [NAME REMOVED] IS QUITE UPSET ABOUT THE ISSUE AND APPARENTLY HAS NOTED THE FDA, HE CONTACTED SALES AND WAS UNDER THE IMPRESSION BY SALES THAT THIS IS A KNOWN ISSUE. I TOLD THE CUSTOMER, I WAS NOT SURE WHAT INFO SALES HAD PROVIDED TO HIM, BUT I WOULD DOCUMENT HIS COMPLAINT AND FORWARDED TO THE PRODUCT MANAGER AND QA GROUP FOR FURTHER ACTION. IF IT IS REQUIRED I WOULD ALSO SEND HIM REPLACEMENT CIRCUITS." THE FOLLOWING DESCRIPTION OF THE EVENT WAS COPIED FROM THE USER FACILITY MEDWATCH REPORT RECEIVED BY CAREFUSION ON 09/14/2009. "TWO VIASYS HFOV CIRCUIT (HIGH FREQUENCY OSCILLATORY VENTILATOR CIRCUITS) WERE DEFECTIVE AT THE CONNECTION NEAR THE CONTROL VALVE. IT KEEPS SLIPPING OFF, NOT STAYING SEALED, LIKE IT SHOULD HAVE BEEN GLUED BUT WAS NOT. NEITHER CIRCUIT WAS CONNECTED TO A PT, SO THERE WAS NOT ANY HARM. ONE WAS NOTICED AFTER IT HAD BEEN IN STORAGE AND THE OTHER ONE WAS FOUND YESTERDAY AS IT WAS GETTING CHECKED PRIOR TO PT USE AS IT WOULD NOT PASS CALIBRATION." "DEVICE USAGE PROBLEM: DEVICE MALFUNCTION THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDINAL HEALTH CIRCUIT, BREATHING (W CON, ADAP, Y PIE) CAI CARDINAL HEALTH 207, INC. NA 050409

    Patients

    Seq Age Sex Outcome Treatment
    1 NA