INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
Report
- Report Number
- 9611451-2023-01191
- Event Type
- Malfunction
- Date Received
- December 21, 2023
- Date of Event
- December 4, 2023
- Report Date
- December 8, 2023
- Manufacturer
- FISHER & PAYKEL HEALTHCARE LTD
- Product Code
- BZE
- UDI-DI
- 09420012431158
- PMA / PMN Number
- SEE H10
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
(B)(4). SECTION G4: 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 K103767. SECTION H10: WE ARE CURRENTLY IN THE PROCESS OF COMPLETING OUR INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT ON COMPLETION OF OUR INVESTIGATION.
(B)(4). SECTION G4: 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 K103767. SECTION H10: METHOD: THE SUBJECT RT268 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS NOT RETURNED TO FISHER & PAYKEL (F&P) HEALTHCARE FOR EVALUATION. OUR INVESTIGATION IS THUS BASED ON THE INFORMATION AND PHOTOGRAPHS PROVIDED BY THE CUSTOMER, AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: VISUAL INSPECTION OF THE PHOTOGRAPH PROVIDED BY THE CUSTOMER IDENTIFIED A CUT IN THE TUBING OF BOTH THE INSPIRATORY AND EXPIRATORY LIMBS OF THE RT268 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT. CONCLUSION: WITHOUT THE RETURN OF THE COMPLAINT DEVICE, WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT. HOWEVER, IT IS LIKELY THAT THE DAMAGED HAS OCCURRED DURING USE AS THE CUSTOMER REPORTED THAT A LEAK TEST WAS PERFORMED BEFORE PATIENT USE AND THE FAULT WAS FIRST DETECTED AFTER AN HOUR OF USE WHEN THE VENTILATOR WAS ALARMING. ALL RT268 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITS ARE VISUALLY INSPECTED, AND PRESSURE AND FLOW TESTED DURING PRODUCTION, AND THOSE THAT FAIL ARE REJECTED. THE SUBJECT BREATHING CIRCUIT WOULD HAVE MET THE REQUIRED SPECIFICATIONS AT THE TIME OF PRODUCTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT268 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT SHOW IN PICTORIAL FORMAT THE CORRECT SET-UP OF THE CIRCUIT AND ALSO STATES THE FOLLOWING: - "VISUALLY INSPECT BREATHING SETS FOR DAMAGE (E.G. A CRUSHED TUBE OR CRACKED CONNECTOR) BEFORE USE, AND REPLACE IF DAMAGED." - "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." - "ENSURE APPROPRIATE VENTILATOR OR FLOW SOURCE ALARMS ARE SET BEFORE CONNECTING BREATHING SET TO PATIENT." - "DO NOT SOAK, WASH OR STERILIZE THIS PRODUCT. AVOID CONTACT WITH CHEMICALS, CLEANING AGENTS, OR HAND SANITIZERS." - "APPROPRIATE PATIENT MONITORING (E.G. OXYGEN SATURATION) MUST BE USED AT ALL TIMES. FAILURE TO MONITOR THE PATIENT (E.G. IN THE EVENT OF AN INTERRUPTION TO GAS FLOW) MAY RESULT IN SERIOUS HARM OR DEATH."
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT A RT268 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT WAS FOUND CRACKED AND LEAKING AIR DURING PATIENT USE. THERE WAS NO PATIENT CONSEQUENCE.
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT A RT268 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT WAS FOUND DAMAGED AND LEAKING DURING PATIENT USE. THE ISSUE WAS IDENTIFIED AFTER ONE HOUR OF USE WHEN THE VENTILATOR WAS ALARMING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2034217 | INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT | BZE | BZE | FISHER & PAYKEL HEALTHCARE LTD | RT268 | 2102658170 | 09420012431158 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |