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

Model Number RT380

Device Problems Crack (1135); Hole In Material (1293)

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

Event Date 01/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The two complaint rt380 adult evaqua2 breathing circuits are expected but have not yet been returned to fisher & paykel healthcare in (b)(4) for investigation to determine if they had a malfunction which caused or contributed to the reported event.We will submit a follow-up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (fph) field representative that the expiratory tube of two rt380 adult dual heated evaqua2 breathing circuits cracked after 11 days of use and 14 days of use respectively.It was reported that tacholiquin was nebulized three times a day and tobramycin was nebulized once a day.No patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: only the expiratory limbs of the two complaint rt380 adult evaqua2 breathing circuits were returned to fisher & paykel healthcare in (b)(4) where they were visually inspected.Results: visual inspection revealed that the expiratory elbow connector, the expiratory patient end connector and the expiratory patient end collar of device 1 were found cracked.Device 1 was also found to be brittle and degraded.Visual inspection of device 2 revealed a cracked expiratory elbow connector and a cracked expiratory patient end collar.Conclusion: based on our knowledge of the product and the results of previous investigations into similar complaints, these failure modes may occur due to a number of reasons, including the use of harsh cleaning chemicals on the breathing circuit, the reuse of the single use circuit, using the circuit for longer than its intended life, and/or possible exposure to uv light.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 healthcare facility in (b)(6) reported via a fisher & paykel healthcare (fph) field representative that the expiratory tube of two rt380 adult dual heated evaqua2 breathing circuits cracked after 11 days of use and 14 days of use respectively.It was reported that tyloxapol was nebulized three times a day and tobramycin was nebulized once a day.No patient consequence was reported.

• Brand Name: ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Type of Device: BZE
• 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: jonathan stevens ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 6355370
• MDR Text Key: 68409804
• Report Number: 9611451-2017-00122
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K122432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT380
• Device Catalogue Number: RT380
• Device Lot Number: 2100078808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/25/2017
• Initial Date FDA Received: 02/23/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• 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: BENNET/MAQUET VENTILATOR