INFANT BIAS FLOW BREATHING CIRCUIT
Report
- Report Number
- 9611451-2011-00114
- Event Type
- Malfunction
- Date Received
- March 2, 2011
- Date of Event
- December 15, 2010
- Manufacturer
- FISHER & PAYKEL HEALTHCARE LIMITED
- Product Code
- BTT
- PMA / PMN Number
- SEE H10
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
(B)(4). (B)(6). THE 510(K): THIS PRODUCT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THIS PRODUCT IS K020332. METHOD: THE COMPLAINT BREATHING CIRCUITS WERE NOT RECEIVED BY FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. AN INVESTIGATION WAS CARRIED OUT BASED ON INFORMATION PROVIDED BY THE CUSTOMER. RESULTS: THE CUSTOMER REPORTED THAT WATER LEAKED FROM THE SWIVEL Y-PIECE OF FOUR RT125 BREATHING CIRCUITS. CONCLUSION: WITHOUT THE RETURN OF THE COMPLAINT BREATHING CIRCUITS FOR EVALUATION, WE ARE UNABLE TO CONFIRM OR DETERMINE THE ROOT CAUSE OF THE REPORTED LEAKS. ALL BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THE RT125 BREATHING CIRCUIT USER INSTRUCTIONS INCLUDE THE FOLLOWING STATEMENTS: 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. FISHER & PAYKEL HEALTHCARE HAS RECEIVED ONE OTHER COMPLAINT OF THIS NATURE FOR RT125 BREATHING CIRCUITS (QUANTITY: 4) WITH LOT NUMBER 100727. THE COMPLAINT WAS RECEIVED FROM THE SAME HOSPITAL IN (B)(6).
(B)(4). (B)(6). THIS PRODUCT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THIS PRODUCT IS K020332. THE COMPLAINT BREATHING CIRCUITS ARE CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE COMPLAINT DEVICES AND COMPLETION OF OUR INVESTIGATION.
(B)(4). THIS PRODUCT IS NOT SOLD IN THE USA, BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THIS PRODUCT IS K020332. METHOD: THREE COMPLAINT BREATHING CIRCUITS WERE FINALLY RECEIVED BY FISHER & PAYKEL HEALTHCARE FOR EVALUATION. THE COMPLAINT DEVICES WERE PRESSURE TESTED AND ALSO SUBMERGED IN A WATER BATH TO TEST FOR LEAKS. RESULTS: THE PRESSURE DROP OVER TIME WAS OUT OF SPECIFICATION. UPON SUBMERSION IN A WATER BATH, THE LEAK WAS CONFIRMED TO BE IN THE SWIVEL IN ALL THREE DEVICES. CONCLUSION: THE LEAK IN THIS INFANT BREATHING CIRCUITS WAS CAUSED BY AN INSUFFICIENT SEAL BETWEEN THE TWO PARTS OF THE INFANT Y-PIECE SWIVEL THAT ARE HELD TOGETHER BY A SNAP-FIT. ALL BREATHING CIRCUITS ARE PRESSURE TESTED DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THE LEAK DEVELOPED POST PRODUCTION. (B)(4). THE RT125 BREATHING CIRCUIT USER INSTRUCTIONS INCLUDE THE FOLLOWING STATEMENTS: 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. FISHER & PAYKEL HEALTHCARE HAS RECEIVED ONE OTHER COMPLAINT OF THIS NATURE FOR RT125 BREATHING CIRCUITS (QUANTITY: 4) WITH LOT NUMBER 100727. THE COMPLAINT WAS RECEIVED FROM THE SAME HOSPITAL IN (B)(6).
A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT FOUR RT125 BREATHING CIRCUITS WERE LEAKING AT THE WYE ADAPTORS.NO PATIENT CONSEQUENCES WERE REPORTED.
A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT FOUR RT125 BREATHING CIRCUITS WERE LEAKING AT THE WYE ADAPTORS. NO PATIENT CONSEQUENCES WERE REPORTED.
A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT FOUR RT125 BREATHING CIRCUITS WERE LEAKING AT THE WYE ADAPTORS. NO PATIENT CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INFANT BIAS FLOW BREATHING CIRCUIT | BTT | BTT | FISHER & PAYKEL HEALTHCARE LIMITED | RT125 | 100727 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |