VENTED AUTOFEED HUMIDIFICATION CHAMBER
Report
- Report Number
- 9611451-2010-00774
- Event Type
- Malfunction
- Date Received
- December 21, 2010
- Date of Event
- November 21, 2010
- Report Date
- November 29, 2010
- Manufacturer
- FISHER & PAYKEL HEALTHCARE LIMITED
- Product Code
- BTT
- PMA / PMN Number
- K934140
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
(B)(4). THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE RECEIVE THE COMPLAINT DEVICE AND HAVE COMPLETED OUR INVESTIGATION.
(B)(4). METHOD: THE RETURNED MR290V HUMIDIFICATION CHAMBER WAS VISUALLY INSPECTED FOR DAMAGE. RESULTS: A SMALL BREAK WAS FOUND BETWEEN THE CONNECTION OF THE WATER FEEDSET TUBE AND WATERBAG SPIKE. FURTHER INSPECTION REVEALED A PIECE OF PLASTIC WAS BROKEN OFF FROM ONE OF THE PORTS OF THE CHAMBER. THE CHAMBER PORT WAS ALSO FOUND CRACKED. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 090718. CONCLUSION: IT IS LIKELY THAT THE WATERBAG SPIKE HAS BEEN PULLED AND THE FEEDSET TUBE HAS BEEN STRETCHED, CAUSING IT TO BREAK. THE CHAMBER PORT IS LIKELY DAMAGED DURING TRANSPORTATION OR STORAGE. EVERY MR290 CHAMBER IS PRESSURE TESTED FOLLOWING THE MANUFACTURING PROCESS TO CHECK FOR ANY LEAKS PRESENT IN THE CHAMBER DOME DUE TO CRACKS AND OTHER CAUSES. IN ADDITION, THE PRESSURE TEST IS FOLLOWED BY A VISUAL INSPECTION OF EACH CHAMBER. ANY CHAMBER WHICH FAILS EITHER OF THESE TESTS IS REJECTED. THIS SUGGESTS THAT THE CHAMBER WAS DAMAGED POST PRODUCTION, POSSIBLY DURING TRANSPORT OR STORAGE AT THE CUSTOMER FACILITY. THE DEVICE USER INSTRUCTIONS STATE THE FOLLOWING: "DO NOT USE THE CHAMBER IF THE SEALS ARE NOT INTACT WHEN RECEIVED, OR IF IT HAS BEEN DROPPED". "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT". (B)(4).
(B)(4). THE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS NOT RETURNED TO FPH (B)(4) FOR FURTHER INVESTIGATION. WITHOUT THE COMPLAINT DEVICE IT IS NOT POSSIBLE TO PROVIDE ANY REASONABLE CONCLUSIONS ABOUT THE REPORTED DEVICE FAILURE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 090718. ALL MR290 CHAMBERS ARE PRESSURE TESTED BEFORE THEY LEAVE THE PRODUCTION LINE AND ANY HOLES OR LEAKS IN THE FEEDSET ARE IDENTIFIED DURING THIS PROCESS. THE USER INSTRUCTIONS WHICH ACCOMPANY THE MR290 CHAMBER STATE: "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTION TO A PATIENT".
A HEALTHCARE FACILITY IN (B)(4) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE WATER FEEDSET OF AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS CUT, CAUSING THE WATER TO LEAK. NO PATIENT CONSEQUENCE WAS REPORTED.
A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE WATER FEEDSET OF AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS CUT, CAUSING THE WATER TO LEAK. NO PATIENT CONSEQUENCE WAS REPORTED.
A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE WATER FEEDSET OF AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS CUT, CAUSING THE WATER TO LEAK. NO PATIENT CONSEQUENCE WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VENTED AUTOFEED HUMIDIFICATION CHAMBER | BTT | BTT | FISHER & PAYKEL HEALTHCARE LIMITED | MR290V | 090718 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |