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

Model Number RT266

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/03/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.

Event Description

A distributor reported on behalf of a healthcare facility in china that the expiratory limb of a rt330 optiflow junior tubing kit was found damaged.There was no patient involvement.

Event Description

A distributor reported on behalf of a healthcare facility in china that the expiratory limb of a rt266 infant dual heated evaqua2 breathing circuit was found damaged.There was no patient involvement.

Manufacturer Narrative

(b)(4).Corrected data: section b5 describe event or problem: a distributor reported on behalf of a healthcare facility in china that the expiratory limb of a rt266 infant dual heated evaqua2 breathing circuit was found damaged.Section d1 brand name: infant dual heated evaqua2 breathing circuit.Section d2 common device name: bze, product code: bze.Section d4 model #; catalog #: rt266; rt266.Method: the complaint rt266 infant dual-heated evaqua2 breathing circuit was returned to fisher & paykel healthcare (f&p) new zealand where it was visually inspected and analyzed.Results: visual inspection of the returned complaint device revealed that the evaqua2 tube was found degraded in several areas.Fourier-transform infrared spectroscopy (ftir) analysis was performed and results showed that the evaqua2 tube material has been chemically attacked.Conclusion: based on the ftir analysis, the evaqua2 tube degraded due to being chemically attacked.All rt266 infant dual-heated evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject infant breathing circuit would have met the required specifications at the time of production.Our user instructions that accompany the rt266 infant dual-heated evaqua2 breathing circuit state the following: "do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers." "do not use medications containing tyloxapol (such as tacholiquin) as this may damage the tubing and lead to a loss of ventilation pressure." "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.".

• Brand Name: INFANT 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 ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 15189371
• MDR Text Key: 297588632
• Report Number: 9611451-2022-00729
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K020332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT266
• Device Catalogue Number: RT266
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/12/2022
• 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