MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE

Model Number RT380

Device Problem Cut In Material (2454)

Patient Problem No Patient Involvement (2645)

Event Date 04/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: two complaint rt380 circuits were received at our fisher & paykel healthcare regional office in (b)(4) and were inspected by a trained technician.Our investigation is based on information and photographs provided by our regional office.Results: visual inspection by our office and our own evaluation of the provided photographs showed that the inspiratory and expiratory limbs of both circuits had a spit in the tubing.The location of the split corresponded with the top edge of the limb when folded in the bag.The location of the cuts in the circuits also matched with the cuts in the packaging bags.The tubing appeared to have been cut with a sharp object.Conclusion: from the appearance and location of the damage to both bags and tubing, we can conclude that the cuts were most likely caused by opening the box or packing bags with a knife or box cutter.All rt380 adult dual-heated evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The user instructions that accompany the rt380 breathing circuit state: perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient; set appropriate ventilator alarms.

Event Description

A hospital in (b)(6) reported that two rt380 evaqua2 adult breathing circuits were found to be 'split' and that the damage was noticed during setup, before patient use.They further commented that two more rt380 circuits had the same issue the previous week, but had been discarded.

• Brand Name: ADULT DUAL HEATED EVAQUA2 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 ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 5665600
• MDR Text Key: 45472388
• Report Number: 9611451-2016-00219
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K122432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT380
• Device Catalogue Number: RT380
• Device Lot Number: 1510280301
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2015
• 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