MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT; BZE

Model Number RT340

Device Problem Air Leak (1008)

Patient Problem No Patient Involvement (2645)

Event Date 03/12/2014

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported via our distributor that they found leakage from the expiratory limb of an rt340 adult breathing circuit during the ventilator leak test.This was found prior to patient use.

Manufacturer Narrative

(b)(4).The complaint rt340 breathing circuit is currently en route to fisher & paykel healthcare in (b)(4) for evaluation.We will provide a follow up report upon completion of our investigation.

Manufacturer Narrative

(b)(4).Method: the complaint rt340 breathing circuit was returned to fisher & paykel healthcare (fph) in (b)(4) and was visually inspected.Results: visual inspection revealed that the evaqua expiratory limb had a hole next to the elbow connector.A lot check revealed two other complaints of this nature for the lot number provided.Conclusion: based on our visual inspection, the subject expiratory limb appeared to have been punctured with a blunt object.All rt340 breathing circuits are visually inspected and pressure tested for leaks before releasing for distribution.Any breathing circuit which fails is discarded.In addition, tube weighing and bond strength testing are performed every 15 minutes.If any faults are detected the whole batch is placed on hold for investigation.This suggests that the subject breathing circuit was damaged after it was released for distribution.The key difference between the evaqua breathing circuits and conventional breathing circuits is that the expiratory limb of the evaqua circuits such as the rt340 is composed of a thin, semi-permeable film specially designed to allow water vapour from expired ventilatory gas to pass through.The evaqua expiratory tube has a protective mesh which prevents damage to the walls of the tube, however the evaqua tubing can be more susceptible to damage than conventional circuits when exposed to rough handling or damage caused by sharp objects and non-fph circuit hangers.The user instructions that accompany the rt340 adult dual heated evaqua breathing circuit state the following: perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient; set appropriate ventilator alarms; fit only the supplied fisher & paykel healthcare circuit hanger with care to avoid circuit damage.The user correctly performed a leak test prior to use, which is in line with our user instructions.

Event Description

A hospital in (b)(6) reported via our distributor that they found leakage from the expiratory limb of an rt340 adult breathing circuit during the ventilator leak test.This was found prior to patient use.

• Brand Name: ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT
• Type of Device: BZE
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: raymond yan ; 15365 barranca parkway; irvine, CA 92618-2216 ; 9494534000
• MDR Report Key: 3744980
• MDR Text Key: 4223456
• Report Number: 9611451-2014-00331
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K983112
• 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,Followup
• Report Date: 03/13/2014

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: RT340
• Device Catalogue Number: RT340
• Device Lot Number: 130309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/13/2014
• Initial Date FDA Received: 04/11/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2013
• 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