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

Model Number MR290V

Device Problem Cut In Material (2454)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/23/2014

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported via our distributor that there was a cut in the water feedset tube of an mr290v vented autofeed humidification chamber.No patient consequence was reported.

Manufacturer Narrative

(b)(4) method: the complaint mr290v vented autofeed humidification chamber was returned to fisher & paykel healthcare in (b)(4) for evaluation.It was visually inspected and connected to a waterbag to test for leaks.Results: small drops of water began to build up at the connection between the water feedset tube and spike.Visual inspection revealed that sufficient amount of glue was present around the spike tubing connection; however, the glue had only partly bonded.A lot check revealed no other complaints of this nature for lot number 130509.Conclusion: we were unable to determine definitively the root cause of the reported fault; however, it is possible that the leaks from the feedset tube was due to the failure of the glue bond that joins the spike to the water feedset tube.Our previous investigation on similar complaints have also shown that such 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 30 newtons.During production, pull testing of the feedset strength at both spike and dome end is performed every hour 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.This suggests that the problem occurred after the product was released for distribution.The user instructions which accompany the mr290 autofeed humidification chambers state the following: "set appropriate ventilator alarms." "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." (b)(4).

• Brand Name: VENTED AUTOFEED HUMIDIFICATION 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: 3643619
• MDR Text Key: 4348570
• Report Number: 9611451-2014-00161
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K934140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2014
• 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: 130509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2013
• 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 RT329