BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 3421300 · Received October 21, 2013

    Report

    Report Number
    9611451-2013-00811
    Event Type
    Malfunction
    Date Received
    October 21, 2013
    Date of Event
    October 11, 2013
    Report Date
    October 11, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT268 INFANT 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 K034026. WE ARE CURRENTLY IN THE PROCESS OF OBTAINING THE COMPLAINT RT268 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITS FROM THE HOSPITAL. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE RECEIVED THE COMPLAINT DEVICES AND COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). FIFTEEN KITS OF RT268 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WERE RETURNED TO FPH IN (B)(4) FOR INVESTIGATION. LOT NUMBER: MANUFACTURING DATE: QUANTITY RETURNED: 130430, 04/30/2013, 12 (1 X UNSEALED). 130527, 05/27/2013, 2. UNKNOWN, UNKNOWN, 1 (1 X UNSEALED). THE RT268 INFANT 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 K034026. METHOD: ONE KIT WITH LOT NUMBER 130430 AND ANOTHER ONE WITH UNKNOWN LOT NUMBER WERE RETURNED IN UNSEALED PLASTIC BAGS. TWO KITS WITH LOT NUMBER 130527 AND 11 KITS WITH LOT NUMBER 130430 WERE RETURNED IN SEALED PLASTIC BAGS. ALL RETURNED RT268 INFANT BREATHING CIRCUITS WERE VISUALLY INSPECTED AND PRESSURE TESTED. RESULTS: THE SWIVEL OF THE RT268 INFANT BREATHING CIRCUIT WITH LOT 130430, WHICH WAS RETURNED UNSEALED, WAS NOT CONNECTED TO THE INSPIRATORY AND THE EXPIRATORY LIMBS. IT IS POSSIBLE THAT IT WAS RETURNED IN SUCH CONDITION OR BECAME LOOSE DURING TRANSPORT. THE SWIVEL WAS FITTED TO THE LIMBS BEFORE THE SUBJECT BREATHING CIRCUIT WAS PRESSURE TESTED. THE PRESSURE TEST RESULT WAS WITHIN SPECIFICATION. THE SWIVELS OF THE OTHER 14 RT268 INFANT BREATHING CIRCUITS WERE PROPERLY ASSEMBLED AND TIGHTLY FITTED ONTO THE LIMBS. THE PRESSURE TEST RESULTS WERE ALSO WITHIN SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBERS 130430 AND 130527. CONCLUSION: NO FAULT WAS FOUND TO THE RETURNED RT268 INFANT BREATHING CIRCUITS. WE CANNOT THEREFORE DETERMINE THE ROOT CAUSE OF THE REPORTED FAULT BASED ON THE RESULTS OF OUR INVESTIGATION AND INFORMATION WE RECEIVED FROM THE HOSPITAL. A SWIVEL OF AN RT268 INFANT BREATHING CIRCUIT CONSISTS OF AN ELBOW AND A Y-PIECE CONNECTOR, WHICH ARE CONNECTED TOGETHER IN OUR PRODUCTION LINE USING A SWIVEL ASSEMBLY MACHINE. ALL ASSEMBLED SWIVELS ARE VISUALLY INSPECTED AND PRESSURE TESTED BEFORE RELEASING FOR DISTRIBUTION, AND THOSE THAT FAIL ARE REJECTED. IF THE SWIVELS HAD NOT BEEN PROPERLY ASSEMBLED AND TIGHTLY FITTED ONTO THE LIMBS, THE SUBJECT BREATHING CIRCUITS WOULD HAVE FAILED THE PRESSURE TEST. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT268 INFANT DUAL HEATED EVAQUA2 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". FPH HAS NOT RECEIVED COMPLAINTS OF ANY SIMILAR INCIDENTS FOR THIS PARTICULAR INFANT BREATHING CIRCUIT.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE TOP SWIVEL HEAD OF AN RT268 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT, WHICH CONNECTS TO THE ENDOTRACHEAL TUBE, CAME APART IN TWO WHILE BEING USED ON A PATIENT. THIS OCCURRED ON TWO DIFFERENT CIRCUITS ATTACHED TO TWO SEPARATE PATIENTS WITHIN 24 HOURS. QUICK INTERVENTION WITH REGARD TO ONE PATIENT PREVENTED ANY DESATURATION, NO FURTHER HARM CAUSED. DESATURATION OF THE SECOND PATIENT OCCURRED VERY QUICKLY. THE PATIENT HAD TO HAVE MANUAL RESUSCITATION TO BRING BACK TO ACCEPTABLE HEART RATE AND OXYGEN SATURATION LEVELS BEFORE PLACING BACK ON THE CIRCUIT, WHICH WAS REPLACED DUE TO THE BROKEN PART. NO FURTHER HARM WITNESSED.

    Description of Event or Problem · 1

    A HOSPITAL IN THE (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE TOP SWIVEL HEAD OF AN RT268 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT, WHICH CONNECTS TO THE ENDOTRACHEAL TUBE, CAME APART IN TWO WHILE BEING USED ON A PATIENT. THIS OCCURRED ON TWO DIFFERENT CIRCUITS ATTACHED TO TWO SEPARATE PATIENTS WITHIN 24 HOURS. QUICK INTERVENTION WITH REGARD TO ONE PATIENT PREVENTED ANY DESATURATION, NO FURTHER HARM CAUSED. DESATURATION OF THE SECOND PATIENT OCCURRED VERY QUICKLY. THE PATIENT HAD TO HAVE MANUAL RESUSCITATION TO BRING BACK TO ACCEPTABLE HEART RATE AND OXYGEN SATURATION LEVELS BEFORE PLACING BACK ON THE CIRCUIT, WHICH WAS REPLACED DUE TO THE BROKEN PART. NO FURTHER HARM WITNESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538230 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT268 SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other