MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED VENTED AUTOFEED CHAMBER; BTT

Model Number MR290V

Device Problem Disconnection (1171)

Patient Problem No Patient Involvement (2645)

Event Date 03/07/2014

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare field representative that the water feedset tube and spike were disconnected when an mr290v vented autofeed humidification chamber kit was opened.This occurred before patient use.

Manufacturer Narrative

(b)(4).Method: the complaint mr290v vented autofeed humidification chamber was returned to fisher & paykel healthcare in (b)(4) and was visually inspected.Results: visual inspection revealed there was a break in the water feedset tube at the point of insertion to the water bag spike.The surface at the break was rough (not smoothly cut).A lot check revealed one other similar complaint of this nature for lot number 130731.Conclusion: the damage appears to be the result of the tube being pulled away from the spike, possibly due to the feedset being caught or under tension.Past investigations have shown that the problem has been caused by the user removing the spike by grasping the tubing instead of the spike.We have conducted extensive testing of the mr290 chamber, with particular emphasis on feedset breaks.Significantly we have not been able to replicate failure of the feedset tube at the chamber dome in any of our testing.The specification for the chamber requires that the feedset tube should have a breaking strain of (b)(4).During production, pull testing of the feedset strength at both spike and dome end is performed (b)(4) on mr290 chambers from each production line.If any faults are detected the whole batch is placed on hold for investigation.Additionally all chambers are pressure tested before they leave the production line and any holes or leaks in the feedset are identified during this process.Chambers that fail any of these tests are discarded.The mr290 was used in conjunction with a fisher & paykel healthcare rt202 adult breathing circuit which user instructions state: "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." "set appropriate ventilator alarms." (b)(4).

• Brand Name: VENTED AUTOFEED CHAMBER
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer Contact: raymond yan ; 15365 barranca parkway; irvine, CA 92618-2216
• MDR Report Key: 3734787
• MDR Text Key: 4222605
• Report Number: 9611451-2014-00309
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K934140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MR290V
• Device Catalogue Number: MR290V
• Device Lot Number: 130731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2014
• Initial Date Manufacturer Received: 03/18/2014
• Initial Date FDA Received: 04/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FISHER & PAYKEL HEALTHCARE RT202 BREATHING CIRCUIT