FISHER & PAYKEL HEALTHCARE
Report
- Report Number
- 9611451-2024-00326
- Event Type
- Malfunction
- Date Received
- May 17, 2024
- Date of Event
- April 15, 2024
- Report Date
- April 18, 2024
- Manufacturer
- FISHER & PAYKEL HEALTHCARE LTD
- Product Code
- BTT
- PMA / PMN Number
- K020332
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). CORRECTIONS: SECTION D2A: COMMON DEVICE NAME UPDATED TO TUBING KIT. SECTION G3: DATE CORRECTED. SECTION D4: THE LOT AND UDI #S OF THE RT330 OPTIFLOW TUBING KITS WERE NOT RECEIVED. SECTION H11: METHOD: THE TWO SUBJECT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS THAT WERE PROVIDED AS PART OF RT330 OPTIFLOW TUBING KITS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN NEW ZEALAND FOR EVALUATION. RESULTS: THE TWO MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE VISUALLY INSPECTED. A HORIZONTAL CRACK AND A STRESSMARK WAS IDENTIFIED ON THE DOME OF ONE OF THE CHAMBERS. BOTH CHAMBERS WERE FOUND WITH THE WATER FEEDSET SPIKE MISSING. CONCLUSION: OUR INVESTIGATION IDENTIFIED A CRACK ON THE DOME OF ONE OF THE CHAMBERS. BOTH CHAMBERS WERE ALSO FOUND WITH THE WATER FEEDSET SPIKE MISSING. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE DAMAGE. EVERY MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER IS PRESSURE TESTED AND VISUALLY INSPECTED FOLLOWING THE MANUFACTURING PROCESS AND ANY HOLES, CRACKS, OR LEAKS WOULD BE IDENTIFIED DURING THIS PROCESS. IN ADDITION, DESTRUCTIVE PULL TESTING IS PERFORMED HOURLY TO VERIFY THE STRENGTH OF THE WATER FEEDSET TUBING. ANY CHAMBER WHICH FAILS THESE TESTS IS REJECTED. THE SUBJECT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WOULD HAVE MET THE REQUIRED SPECIFICATIONS AT THE TIME OF PRODUCTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT330 OPTIFLOW TUBING KIT STATE THE FOLLOWING: DO NOT USE THE CHAMBER IF THE SEALS ARE NOT INTACT WHEN RECEIVED, OR IF IT HAS BEEN DROPPED. ENSURE THERE IS A WATER SUPPLY CONNECTED TO THE CHAMBER AND THAT WATER IS PRESENT WITHIN THE CHAMBER. APPROPRIATE PATIENT MONITORING (E.G. OXYGEN SATURATION) MUST BE USED AT ALL TIMES. ENSURE APPROPRIATE VENTILATOR OR FLOW SOURCE ALARMS ARE SET BEFORE CONNECTING BREATHING SETS TO PATIENT. VISUALLY INSPECT BREATHING SETS FOR DAMAGE (E.G. CRUSHED TUBE OR CRACKED CONNECTOR) BEFORE USE AND REPLACE IF DAMAGED.
(B)(4). THE TWO SUBJECT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS HAVE BEEN REQUESTED TO BE RETURNED TO FISHER & PAYKEL HEALTHCARE IN NEW ZEALAND FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.
(B)(4). CORRECTIONS: SECTION B4: CORRECTED YEAR. SECTION D1: CORRECTED BRAND NAME. SECTION D2A: CORRECTED COMMON DEVICE NAME SECTION D4: MODEL AND CATALOG # CORRECTED TO RT330. SECTION G4: UPDATED 510(K). SECTION D4: THE LOT AND UDI #S OF THE RT330 OPTIFLOW TUBING KITS WERE NOT RECEIVED. SECTION H11: METHOD: THE TWO SUBJECT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS THAT WERE PROVIDED AS PART OF RT330 OPTIFLOW TUBING KITS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN NEW ZEALAND FOR EVALUATION. RESULTS: THE TWO MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE VISUALLY INSPECTED. A HORIZONTAL CRACK AND A STRESSMARK WAS IDENTIFIED ON THE DOME OF ONE OF THE CHAMBERS. BOTH CHAMBERS WERE FOUND WITH THE WATER FEEDSET SPIKE MISSING. CONCLUSION: OUR INVESTIGATION IDENTIFIED A CRACK ON THE DOME OF ONE OF THE CHAMBERS. BOTH CHAMBERS WERE ALSO FOUND WITH THE WATER FEEDSET SPIKE MISSING. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE DAMAGE. EVERY MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER IS PRESSURE TESTED AND VISUALLY INSPECTED FOLLOWING THE MANUFACTURING PROCESS AND ANY HOLES, CRACKS, OR LEAKS WOULD BE IDENTIFIED DURING THIS PROCESS. IN ADDITION, DESTRUCTIVE PULL TESTING IS PERFORMED HOURLY TO VERIFY THE STRENGTH OF THE WATER FEEDSET TUBING. ANY CHAMBER WHICH FAILS THESE TESTS IS REJECTED. THE SUBJECT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WOULD HAVE MET THE REQUIRED SPECIFICATIONS AT THE TIME OF PRODUCTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT330 OPTIFLOW TUBING KIT STATE THE FOLLOWING: DO NOT USE THE CHAMBER IF THE SEALS ARE NOT INTACT WHEN RECEIVED, OR IF IT HAS BEEN DROPPED. ENSURE THERE IS A WATER SUPPLY CONNECTED TO THE CHAMBER AND THAT WATER IS PRESENT WITHIN THE CHAMBER. APPROPRIATE PATIENT MONITORING (E.G. OXYGEN SATURATION) MUST BE USED AT ALL TIMES. ENSURE APPROPRIATE VENTILATOR OR FLOW SOURCE ALARMS ARE SET BEFORE CONNECTING BREATHING SETS TO PATIENT. VISUALLY INSPECT BREATHING SETS FOR DAMAGE (E.G. CRUSHED TUBE OR CRACKED CONNECTOR) BEFORE USE AND REPLACE IF DAMAGED.
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN COLUMBUS, USA, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT TWO MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS, PROVIDED WITH RT330 OPTIFLOW¿ JUNIOR BREATHING CIRCUIT KITS, WERE FOUND TO BE LEAKING WATER. THERE WAS NO PATIENT HARM.
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN COLUMBUS, USA, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT TWO MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE FOUND TO BE LEAKING WATER. THERE WAS NO PATIENT HARM.
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN COLUMBUS, USA, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT TWO MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS, PROVIDED WITH RT330 OPTIFLOW¿ JUNIOR BREATHING CIRCUIT KITS, WERE FOUND TO BE LEAKING WATER. THERE WAS NO PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2500221 | FISHER & PAYKEL HEALTHCARE | TUBING KIT | BTT | FISHER & PAYKEL HEALTHCARE LTD | RT330 | SEE H11 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | F&P RT330 OPTIFLOW¿ JUNIOR BREATHING CIRCUIT KIT |