ADULT INSPIRATORY-HEATED BREATHING CIRCUIT
Report
- Report Number
- 9611451-2012-00324
- Event Type
- Malfunction
- Date Received
- May 21, 2012
- Date of Event
- April 13, 2012
- Report Date
- April 30, 2012
- Manufacturer
- FISHER & PAYKEL HEALTHCARE LIMITED
- Product Code
- BTT
- PMA / PMN Number
- SEE H10
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER
Narratives
(B)(4). LOT NUMBER: 110920, MANUFACTURING DATE: 09/20/2011, QUANTITY AFFECTED 1. LOT #:111107, MFG DATE: 11/07/2011, QTY AFFECTED: 3. LOT#: 120119, MFG DATE: 01/19/2012, QTY AFFECTED 1. THE RT443 ADULT INSPIRATORY-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. THE COMPLAINT RT443 ADULT BREATHING CIRCUIT IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.
(B)(4). LOT NUMBER: 110920, 111107, 120119; MANUFACTURING DATE: 09/20/2011, 11/07/2011, 01/19/2012; (B)(4). THE RT443 ADULT INSPIRATORY-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. METHOD: THE RT443 ADULT INSPIRATORY-HEATED BREATHING CIRCUIT KIT WAS RETURNED TO FPH IN (B)(4) FOR INSPECTION. THE COMPLAINT 5.5 MM PRESSURE LINE OF THE RETURNED RT443 ADULT BREATHING CIRCUIT KIT WAS VISUALLY INSPECTED. THE OUTER AND INNER DIMENSIONS OF BOTH ENDS OF THE SUBJECT PRESSURE LINE WERE ALSO MEASURED USING A DIGITAL CALLIPER. RESULTS: THE RT443 ADULT BREATHING CIRCUIT KIT WAS STILL SEALED WHEN RECEIVED. THE PRESSURE LINE INSIDE THE SEALED KIT WAS DETACHED FROM THE EXHALATION TUBE. THE PRESSURE LINE ADAPTOR CONNECTION WAS ALSO LOOSE. BOTH THE OUTER DIAMETERS AND ONE OF THE INNER DIAMETERS OF THE PRESSURE LINE ENDS WERE WITHIN THE REQUIRED SPECIFICATIONS. HOWEVER, THE INNER DIAMETER OF THE PRESSURE LINE END THAT CONNECTS TO THE EXHALATION TUBE WAS SLIGHTLY LARGER THAN SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBERS 110920 AND 120119. A LOT CHECK REVEALED TWO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 111107. CONCLUSION: ALTHOUGH THE INNER DIAMETER OF ONE OF THE PRESSURE LINE ENDS WAS OUTSIDE THE SPECIFICATION, IT SHOULD BE NOTED THAT IT WAS THE PRESSURE LINE END THAT WAS INSERTED INTO THE EXHALATION TUBE. ITS INNER DIAMETER WILL HAVE INCREASED DUE TO IT BEING FORCED ONTO THE EXHALATION TUBE. THE PRESSURE LINES OF THE RT443 ADULT BREATHING CIRCUITS ARE INSERTED ONTO THE EXHALATION TUBES PRIOR TO LEAVING THE PRODUCTION LINE. THIS SUGGESTS THE SUBJECT PRESSURE LINE WAS DETACHED POST PRODUCTION, POSSIBLY DURING TRANSPORTATION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT443 ADULT INSPIRATORY-HEATED BREATHING CIRCUIT STATE THE FOLLOWING: "CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE." "CHECK SYSTEM FOR LEAKS BEFORE CONNECTING TO PATIENT." "VERIFY CORRECT OPERATION BEFORE CONNECTING TO THE PATIENT."
A DISTRIBUTOR IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE PRESSURE LINE OF THE EXHALATION VALVE OF AN RT443 ADULT INSPIRATORY-HEATED BREATHING CIRCUIT WAS "SLIPPING OFF EVERY EASY", AND SOMETIMES ALREADY DISCONNECTED WHEN RECEIVED.
A DISTRIBUTOR IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE PRESSURE LINE OF THE EXHALATION VALVE OF AN RT443 ADULT INSPIRATORY-HEATED BREATHING CIRCUIT WAS "SLIPPING OFF EVERY EASY", AND SOMETIMES ALREADY DISCONNECTED WHEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADULT INSPIRATORY-HEATED BREATHING CIRCUIT | BTT | BTT | FISHER & PAYKEL HEALTHCARE LIMITED | RT443 | SEE H10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |