BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADUL DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2107146 · Received May 31, 2011

    Report

    Report Number
    9611451-2011-00321
    Event Type
    Malfunction
    Date Received
    May 31, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 9, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    REFER TO H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K): THE (B)(4) ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. METHOD: THE RETURNED (B)(4) BREATHING CIRCUIT WAS VISUALLY INSPECTED FOR DAMAGE. FPH ALSO REQUESTED SPECIFIC DETAILS OF THE TYPE OF DRUGS USED BY THE HOSPITAL WITH THE SUBJECT BREATHING CIRCUIT. RESULTS: VISUAL INSPECTION REVEALED THAT THE EVAQUA FILM OF THE EXPIRATORY TUBE OF THE RETURNED (B)(4) BREATHING CIRCUIT WAS BREAKING AND SEPARATING. THE HOSPITAL REPORTED THAT TYLOXAPOL DRUG WAS USED WITH THE AFFECTED BREATHING CIRCUIT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 101129. CONCLUSION: THIS TYPE OF DAMAGE TO THE EVAQUA EXPIRATORY TUBE IS MOST LIKELY DUE TO THE USE OF TYLOXAPOL DRUG. AN INVESTIGATION CONDUCTED LAST YEAR CONFIRMED THAT TYLOXAPOL (TACHOLIQUIN) CAN DAMAGE THE DELICATE FILM OF EVAQUA TUBING. THE USER INSTRUCTIONS FOR (B)(4) BREATHING CIRCUIT HAS SINCE BEEN REVISED TO PROVIDE THE WARNING: "DO NOT USE MEDICATIONS CONTAINING TYLOXAPOL (SUCH AS TACHOLIQUIN) AS THIS MAY DAMAGE THE TUBING AND LEAD TO A LOSS OF VENTILATION PRESSURE". THIS IS THE ONLY COMPLAINT OF THIS NATURE THAT WE RECEIVED FOR (B)(4) ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT IN THE LAST YEAR TO THE END OF (B)(6) 2011.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. THE RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE RECEIVE THE COMPLAINT DEVICE AND HAVE COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT AIR LEAKED FROM THE EXPIRATORY TUBE OF AN RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT AFTER ABOUT A WEEK OF USE. IT WAS FURTHER REPORTED THAT SEVERAL SLITS WERE FOUND ON THE EXPIRATORY TUBE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT AIR LEAKED FROM THE EXPIRATORY TUBE OF AN (B)(4) ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT AFTER ABOUT A WEEK OF USE. IT WAS FURTHER REPORTED THAT SEVERAL SLITS WERE FOUND ON THE EXPIRATORY TUBE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADUL DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT340 101129

    Patients

    Seq Age Sex Outcome Treatment
    1