BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED BREATHING CIRCUIT

    MDR report key: 2968641 · Received February 19, 2013

    Report

    Report Number
    9611451-2013-00121
    Event Type
    Malfunction
    Date Received
    February 19, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 24, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT200 ADULT DUAL-HEATED BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. WE ARE CURRENTLY IN THE PROCESS OF OBTAINING THE COMPLAINT RT200 BREATHING CIRCUIT FROM THE MEDICAL CENTRE. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE RECEIVED THE COMPLAINT DEVICE AND COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT200 ADULT DUAL-HEATED BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112.LOT NUMBER QUANTITY AFFECTED MANUFACTURING DATE120203 1 02/03/2012120201 1 02/01/2012METHOD: TWO RT200 ADULT BREATHING CIRCUITS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE FOR INSPECTION. THE RETURNED DEVICES WERE VISUALLY INSPECTED FOR DAMAGE AND PRESSURE TESTED FOR LEAKS. RESULTS: NO PHYSICAL DAMAGE WAS OBSERVED TO THE EXPIRATORY TUBES. FURTHER INSPECTION OF THE RETURNED DEVICES REVEALED THAT THERE WAS A HOLE IN THE DRYLINE TUBE OF THE BREATHING CIRCUIT WITH LOT NUMBER 120203. THE HOLE WAS LOCATED ABOUT 4.5CM FROM THE CONNECTOR. THE PRESSURE TEST RESULT OF THE BREATHING CIRCUIT WITH LOT NUMBER 120201 WAS WITHIN SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBERS 120203. CONCLUSION: THE REPORTED LEAKS ON THE EXPIRATORY TUBES WERE NOT CONFIRMED DURING INSPECTION. IT WAS IDENTIFIED THAT DAMAGE TO THE RT200 DRYLINE WAS CAUSED BY A FAULTY CORRUGATOR BLOCK THAT WAS USED DURING THE DRYLINE MANUFACTURING PROCESS. THE FAULTY CORRUGATOR BLOCK WAS REPLACED LAST YEAR. THE DAMAGED DRYLINE TUBE WAS MANUFACTURED PRIOR TO THE REPLACEMENT OF THE FAULTY CORRUGATOR BLOCK. DURING THE PRODUCTION OF THE DRYLINE TUBES, A PRESSURE TEST IS PERFORMED EVERY 10 TO 15 MINTURES AND THOSE THAT FAIL ARE SET ASIDE FOR FURTHER INSPECTION. THE USER INSTRUCTIONS FOR THE RT200 ADULT DUAL-HEATED BREATHING CIRCUIT STATE THE FOLLOWING: "CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE." "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." "SET APPROPRIATE VENTILATOR ALARMS."

    Description of Event or Problem · 1

    A MEDICAL CENTRE IN (B)(6) REPORTED TO A DISTRIBUTOR THAT A LEAK WAS FOUND IN THE EXPIRATORY LIMB AN RT200 ADULT DUAL-HEATED BREATHING CIRCUIT. THIS WAS OBSERVED DURING USE BUT NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A MEDICAL CENTRE IN (B)(6) REPORTED TO A DISTRIBUTOR THAT AIR LEAKED FROM AN RT200 ADULT DUAL-HEATED BREATHING CIRCUIT DURING USE DUE TO A FAULTY EXPIRATORY TUBE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72162 ADULT DUAL-HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT200 120203 AND 120201

    Patients

    Seq Age Sex Outcome Treatment
    1