MAUDE Adverse Event Report: ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE

Model Number RT380

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/21/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint rt380 evaqua 2 adult breathing circuit is currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow-up report upon completion of our investigation.

Event Description

A distributor in (b)(4) reported on behalf of a healthcare facility that a rt380 adult dual heated evaqua2 breathing circuit was found to be leaking during device set-up.It was also reported that a crack was found on the connector.There was no patient involvement.

Event Description

A distributor in japan reported on behalf of a healthcare facility that a rt380 adult dual heated evaqua2 breathing circuit was found to be leaking during device set-up.It was also reported that a crack was found on the connector.Additional information was later reported by the customer noting that the rt380 circuit was used for approximately 1.5 months and nebulizing drug acetylcysteine was used.There was no patient involvement.

Manufacturer Narrative

Ps346496 method: the complaint rt380 adult dual heated evaqua2 breathing circuit was received at fisher & paykel healthcare (f&p) in new zealand where it was visually inspected and analysed.Results: visual inspection of the returned circuit confirmed that the patient end evaqua2 collar was cracked.It was also noted that the inner connector was missing.Further analysis of the complaint device revealed the surface of the collar has tree-ring like deformation patterns that are typical of environmental stress cracking which form due to chemical exposure or contact.Conclusion: based on previous investigations of similar complaints, the crack is most likely due to the collar being in contact with a chemical resulting in environmental stress cracking.It should also be noted that the rt380 circuit was used for approximately 1.5 months and nebulizing drug acetylcysteine was used.All rt380 circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject circuit would have met the required specifications at the time of production.The user instructions that accompany the rt380 adult dual heated evaqua2 breathing circuit states: "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." "do not use beyond 14 days maximum duration of use.".

• Brand Name: ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Type of Device: BZE
• MDR Report Key: 10475071
• MDR Text Key: 207367630
• Report Number: 9611451-2020-00746
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• PMA/PMN Number: K122432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• 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: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Date Manufacturer Received: 09/24/2020
• 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