BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 2917178 · Received January 15, 2013

    Report

    Report Number
    9611451-2013-00045
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 17, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K122432
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT380 ADULT DUAL-HEATED EVAQUA2 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. LOT: 120202, 120712, 120611; DEVICE MANUFACTURER DATE: 120202 - 02/02/2012, 120712 - 07/12/2012, 120611 - 06/11/2012. THE COMPLAINT BREATHING CIRCUITS HAVE BEEN RETURNED TO THE MANUFACTURER RECENTLY AND IS CURRENTLY BEING EVALUATED. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE TWO COMPLAINT RT380 CIRCUITS WERE SUPPLIED WITH THREE CIRCUIT BAGS, WITH THREE DIFFERENT LOT NUMBERS: 120202 - MANUFACTURE DATE 02/02/2012, 120712 - MANUFACTURE DATE 07/12/2012, 120611 - MANUFACTURE DATE 06/11/2012. METHOD: THE RETURNED COMPLAINT BREATHING CIRCUITS WERE VISUALLY INSPECTED FOR DAMAGE. A HEATER WIRE RESISTANCE TEST WAS PERFORMED. A SAMPLE OF THE COMPLAINT TUBING WAS ALSO SENT TO THE (B)(4) INSTITUTE LTD FOR TESTING, USING NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY, ATTENUATED TOTAL REFLECTANCE FOURIER TRANSFORM INFRARED SPECTROSCOPY AND GEL PERMEATION CHROMATOGRAPHY. ADDITIONALLY THE HOSPITAL RETURNED NINE OTHER UNUSED RT380 CIRCUITS FROM THE SAME THREE LOTS: TWO FROM LOT 120119, FIVE FROM LOT 120202 AND TWO FROM LOT 120720. THESE CIRCUITS WERE ALL VISUALLY INSPECTED, AND PRESSURE AND RESISTANCE TESTED. RESULTS: IN BOTH COMPLAINT CIRCUITS, THE EVAQUA2 (EXPIRATORY) LIMB WAS FOUND TO BE DEGRADED AND DISCOLOURED ABOUT 90CM FROM THE PATIENT END CONNECTOR. THE NON DEGRADED PART OF THE LIMB DID NOT SHOW THE SAME DISCOLOURATION. THE DISCOLOURATION WAS ONLY PRESENT ON THE OUTSIDE OF THE LIMB. THE RESISTANCE OF THE INSPIRATORY AND EXPIRATORY HEATER WIRES OF BOTH CIRCUITS WAS FOUND TO BE WITHIN SPECIFICATION. ALL THREE TECHNIQUES USED IN THE TESTING BY (B)(4) INSTITUTE (1H NMR, FT-IR, & GPC) TO ANALYSE THE DEGRADED AND NON DEGRADED PORTIONS OF THE SUPPLIED TUBING INDICATE THAT THE LIKELY SOURCE OF THE DEGRADATION IS HYDROLYSIS OF THE POLYMER. SPECIFICALLY THE 1H NMR SHOWS THE PRESENCE IN THE DEGRADED SECTION OF AN EXCHANGING PROTON IN THE ALCOHOL REGION OF THE SPECTRA, FT-IR GIVES EVIDENCE OF THE APPEARANCE OF CARBOXYLIC ACID GROUPS, AND GPC SHOWS A DECREASE IN THE OVERALL MOLECULAR WEIGHT PROFILE. FOLLOWING ON FROM THIS ANALYSIS, A REVIEW OF THE MANUFACTURING PROCESS WAS PERFORMED. NO CHEMICALS OR PROCESSES THAT CAN CAUSE HYDROLYSIS OF THE EVAQUA2 MATERIAL WERE IDENTIFIED IN THE MANUFACTURING PROCESS. THE NINE RETURNED UNUSED CIRCUITS WERE ALL FOUND TO BE WITHOUT DEFECT OR MALFUNCTION. CONCLUSION: BASED ON THE RESULTS OF OUR INVESTIGATION, WE ARE UNABLE TO DETERMINE WHAT HAS CAUSED THE DAMAGE TO THE TWO RT380 EXPIRATORY LIMBS. THE HOSPITAL IS A LONG TERM USER OF THE PRODUCT AND HAVE STATED THAT THIS TYPE OF DAMAGE TO THE EVAQUA2 LIMBS HAD NOT BEEN SEEN BEFORE OR SINCE THIS INCIDENT. FURTHER INFORMATION ELICITED FROM THE HOSPITAL WITH REGARD TO THIS INCIDENT DID NOT SHED ANY LIGHT ON A POSSIBLE CAUSE FOR THE OBSERVED DAMAGE. ALL RT380 BREATHING CIRCUITS ARE PRESSURE TESTED BEFORE LEAVING THE PRODUCTION LINE AND THOSE THAT FAIL ARE DISCARDED. IT IS THEREFORE MOST LIKELY THAT THE DAMAGE OCCURRED AFTER LEAVING OUR PRODUCTION FACILITY. WE WILL CONTINUE TO MONITOR FOR ANY FUTURE COMPLAINTS OF THIS NATURE THROUGH OUR ROBUST PRODUCT SURVEILLANCE PROCESS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(4) REPORTED THAT TWO RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUITS WERE "YELLOW" AND "DEVELOPED HOLES". THIS WAS REPORTED PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT TWO RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUITS WERE "YELLOW" AND "DEVELOPED HOLES". THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22308 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT380 120611

    Patients

    Seq Age Sex Outcome Treatment
    1