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

Model Number RT380

Device Problems Crack (1135); Device Handling Problem (3265)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: four parts of the rt380 adult dual-heated evaqua2 breathing circuits were returned to fph in (b)(6) for evaluation: the elbow connector and part of the evaqua tube (device 1), the patient end connector and part of the evaqua tube (device 2), the elbow connector and part of the evaqua tube (device 3) and a part of the evaqua tube (device 4).The subject breathing circuits were visually inspected.Results: visual inspection of the complaint devices revealed that the expiratory elbow were found cracked (device 1 and device 3), the patient end connector were found cracked and the evaqua tube was found to be brittle and degraded (device 2) and the evaqua tube was found to be brittle and degraded (device 4).A lot check was not performed as lot information was not provided.Conclusion: the hospital informed fph that the hospital is disinfecting breathing circuit systems before use.It is possible that the affected breathing circuits also came into contact with a chemical solution, resulting in environmental stress cracking of the connectors and leading to a degradation of the expiratory limbs.All rt380 adult breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject rt380 adult breathing circuits would have met the required specification at the time of production.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

A hospital in (b)(6) reported via a fisher & paykel healthcare (fph) field representative that the connection part of the expiratory limb of three rt380 adult dual heated evaqua2 breathing circuits has been found cracked.No patient consequence was reported.

• 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 dr. suite 100; irvine, CA 92618 ; 8007923912
• MDR Report Key: 5884929
• MDR Text Key: 52383838
• Report Number: 9611451-2016-00454
• 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
• Report Date: 07/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2016
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/20/2016
• 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