BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEFANT CONTINOUS FLOW BREATHING CIRCUIT

    MDR report key: 1172305 · Received September 19, 2008

    Report

    Report Number
    9611451-2008-00546
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Report Date
    August 27, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K020332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO COMPLAINT DEVICES WERE RETURNED TO FISHER & PAYKEL HEALTHCARE ("FPH") FOR INVESTIGATION. AN FPH CLINICAL PRODUCT SPECIALIST MADE A SITE VISIT TO THE NEONATAL INTENSIVE CARE UNIT OF THE HOSPITAL IN 2008. THE PRODUCT SPECIALIST OBSERVED A TOTAL OF 6 EQUIPMENT SET-UPS ON BOTH VENTILATOR AND SIPAP APPLICATIONS. RESULTS: NONE OF THE 6 EQUIPMENT SET-UPS WERE CORRECT. NO TEMPERATURE PROBE COVERS (REFLECTIVE SHIELDS) WERE UTILIZED IN THE SET-UPS INVOLVING INFANT RADIANT WARMERS. IN ADDITION, TEMPERATURE PROBE COVERS AND UNHEATED EXTENSIONS WERE NOT PROPERLY USED, AND THE PLACEMENT OF THE AIRWAY TEMPERATURE PROBES WAS INCORRECT IN SET-UPS INVOLVING INCUBATORS. CONCLUSION: THE PURPOSE OF THE REFLECTIVE SHIELD IS TO PROTECT THE AIRWAY TEMPERATURE PROBE FROM RADIANT HEAT FROM THE INFANT WARMER. WITHOUT THIS PROTECTION, HEAT FROM THE INFANT WARMER CAN CAUSE THE TEMPERATURE PROBE TO GIVE AN ERRONEOUSLY HIGH READING, WHICH SIGNALS THE MR850 HUMIDIFIER TO PRODUCE LESS HEAT. THE REDUCTION IN HEATING WITHIN THE BREATHING CIRCUIT CAN CAUSE AN INCREASE IN THE AMOUNT OF CONDENSATION FORMING. FPH'S PRODUCT SPECIALIST RE-EDUCATED HOSPITAL STAFF ON THE CORRECT USE OF REFLECTIVE SHIELDS, UNHEATED EXTENSIONS AND CORRECT TEMPERATURE PROBE PLACEMENT. THE FPH RT020 OR MAQUET EXPIRATORY FILTER AND THE RT130 BREATHING CIRCUIT WHICH CONTAINS A WATER TRAP WERE RECOMMENDED. THE HOSPITAL, HAVING ADOPTED THE CHANGES, SUBSEQUENTLY REPORTED FAVORABLE RESULTS.

    Description of Event or Problem · 1

    REPORTER REPORTED TO A FISHER & PAYKEL HEALTHCARE CLINICAL PRODUCT SPECIALIST OF EXCESSIVE RAINOUT (CONDENSATION) OCCURRING IN THE NEONATAL INTENSIVE CARE UNIT WITH SET-UPS CONSISTING OF THE RT132 INFANT CONTINUOUS FLOW BREATHING CIRCUIT IN APPLICATIONS UTILISING SIPAP, CARDINAL BREATHING CIRCUIT WITH, AND WITHOUT THE AEROGEN SOLO NEBULIZER, MR850 RESPIRATORY HUMIDIFIER AND THE SERVO-I VENTILATOR. THE HOSPITAL FURTHER REPORTED THE FOLLOWING: THAT EXPIRATORY RAINOUT WAS CAUSING THE EXPIRATORY FILTER AND EXPIRATORY BLOCK/CARTRIDGE TO BECOME WET. THAT STAFF HAD BEEN ADVISED BY ANOTHER DISTRIBUTOR TO MOUNT THE AEROGEN NEBULIZER AT THE HUMIDIFICATION CHAMBER, NOT IN THE AREA BETWEEN THE AIRWAY TEMPERATURE PROBE AND BREATHING CIRCUIT WYE AS RECOMMENDED BY FISHER & PAYKEL HEALTHCARE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEFANT CONTINOUS FLOW BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT132

    Patients

    Seq Age Sex Outcome Treatment
    1 CARDINAL BREATHING CIRCUIT| MR850 HUMIDIFIER| AEROGEN SOLO NEBULIZER| SERVI-I VENTILATOR