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

Model Number RT380

Device Problems Fracture (1260); Leak/Splash (1354)

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

Event Date 10/15/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The expiratory limb of the complaint rt380 adult dual heated evaqua2 breathing circuit was received at fisher & paykel healthcare in (b)(4) and was visually inspected and pressure tested.Visual inspection confirmed that the expiratory limb collar was cracked and the results of the pressure test were outside of specification.The healthcare facility confirmed that the device had passed initial leak testing.We were unable to determine conclusively what had caused the collar to crack; however, based on our previous investigations it is possible that the crack is due to being in contact with a chemical solution, resulting in environmental stress cracking.All rt380 circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The user instructions that accompany the rt380 adult dual heated evaqua2 breathing circuit state: "do not soak, wash, sterilize or reuse this product.Avoid contact with chemicals, cleaning agents or hand sanitizers." "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

Our distributor in (b)(6) reported on behalf of a healthcare facility that they found a crack on the collar of the expiratory limb of an rt380 adult dual heated evaqua2 breathing circuit after one week of use.There was no reported patient consequence.

• 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, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: faranak gomarooni ; 173 technology dr.; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 8118432
• MDR Text Key: 129485294
• Report Number: 9611451-2018-01018
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K122432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Date Manufacturer Received: 10/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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