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

Model Number RT340

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/25/2013

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare field representative that water leaked from the glue port on the expiratory limb of an rt340 adult breathing circuit after four days of use.No patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: the complaint rt340 breathing circuit was returned to fisher & paykel healthcare (fph) in (b)(6) and was visually inspected.The complaint breathing circuit was also placed in a water bath to determine the source of the leak.Results: visual inspection revealed that there was no leak or issue with the glue port as reported by the customer.However, the water bath test identified a leak in the circuit itself and subsequent visual examination revealed a hole in the evaqua expiratory limb, about 25cm from the proximal connector.A lot check revealed no other complaints for the lot number provided.Conclusion: based on the inspection conducted, 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 release 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.The hospital had reported that the leak was only found after four days of use on a patient, which suggests that the circuit became damaged at that time.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.

• 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: 3601053
• MDR Text Key: 4161006
• Report Number: 9611451-2014-00094
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K983112
• 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: 10/29/2013

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: 121128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2013
• Initial Date Manufacturer Received: 01/31/2014
• Initial Date FDA Received: 01/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2012
• 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