BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAREFUSION

    MDR report key: 4992521 · Received August 11, 2015

    Report

    Report Number
    2021710-2015-01383
    Event Type
    Injury
    Date Received
    August 11, 2015
    Date of Event
    May 22, 2015
    Report Date
    July 13, 2015
    Manufacturer
    CAREFUSION
    Product Code
    BTY
    PMA / PMN Number
    K981366
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE NON-CAREFUSION PROVIDED DLCO GAS REGULATOR WAS NOT RETURNED TO ASSESS THE FITTINGS. ONLY THE DLCO HOSE (PART NUMBER 770215) WAS RECEIVED FOR EVALUATION. THE HOSE WAS VISUALLY INSPECTED WITH NO ABNORMALITIES OBSERVED. THE HOSE WAS CONNECTED TO A STANDARD TEST SET-UP AND PRESSURIZED. THERE WERE NO BULGES ("BUBBLING") OR LEAKS DETECTED DURING THE TESTING.

    Description of Event or Problem · 1

    THE REGISTERED RESPIRATORY THERAPIST CALLED TO REQUEST A REPLACEMENT DLCO HOSE FOR HER SYSTEM WITH THE ALLEGATION THAT THE HOSE HAS A "BUBBLE". A REPLACEMENT HOSE WAS SENT; HOWEVER THE CLINICIAN RETURNED THE CALL AFTER RECEIPT INDICATING THAT SHE REQUIRED AN ADAPTOR TO ENABLE HER TO CONNECT THE HOSE TO THE DLCO GAS REGULATOR. THE REGULATOR IN USE AT THE FACILITY WAS NOT A CAREFUSION PROVIDED REGULATOR. UPON FURTHER FOLLOW-UP WITH THE CLINICIAN SHE ADVISED US THAT FOR MORE THAN TWO WEEKS SHE WAS "DIZZY, WITH HEADACHES AND COUGHING, BEFORE DETECTING THE LEAK, I HAD TO OPEN THE WINDOWS CONSTANTLY BECAUSE I WAS ALWAYS COUGHING AND IRRITATED, ALL OF WHICH WERE ALLEVIATED WHEN THE LEAK WAS CONTAINED BY THE REPLACEMENT OF THE HOSE AND PROPER SEAL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523412 CAREFUSION CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION BTY CAREFUSION 22 E

    Patients

    Seq Age Sex Outcome Treatment
    1