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

Model Number RT380

Device Problems Crack (1135); Gas/Air Leak (2946)

Patient Problem Low Oxygen Saturation (2477)

Event Date 03/15/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).The subject rt380 adult dual-heated evaqua2 breathing circuits have been requested to return to f&p nz for evaluation to determine our involvement in the reported event.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported that the collar of four rt380 adult dual heated evaqua2 breathing circuits had cracked during use.It was further reported that one patient desaturated to 76% spo2 and experienced respiratory arrest.No further patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: two of the four complaint rt380 adult dual heated evaqua2 breathing circuits were received at fisher & paykel healthcare (f&p) in new zealand where they were visually inspected and analysed.Results: visual inspection of the two returned rt380 adult dual heated evaqua2 breathing circuits confirmed that the patient end evaqua2 collars were cracked.It was also noted that the inspiratory tube of one of the returned complaint rt380 adult dual heated evaqua2 breathing circuits was partially pulled apart from the patient end connector.Further analysis of the returned complaint devices revealed the surface of the collars had tree-ring like deformation patterns that are typical of environmental stress cracking which form due to chemical exposure or contact.Conclusion: the observed cracks are most likely due to the collar being in contact with a chemical resulting in environmental stress cracking.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 subject circuits 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.".

Event Description

A healthcare facility in spain reported, via a fisher & paykel healthcare (f&p) field representative, that the collar of four rt380 adult dual heated evaqua2 breathing circuits had cracked during use.It was further reported that the patients using the rt380 adult dual heated evaqua2 breathing circuits desaturated.One of these patients desaturated to 76% spo2 and experienced respiratory arrest.This patient was provided alternative therapy and the rt380 circuit was replaced.No further patient consequences were reported.

• Brand Name: ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Type of Device: BZE
• MDR Report Key: 11676285
• MDR Text Key: 248166109
• Report Number: 9611451-2021-00405
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/18/2021

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: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Initial Date Manufacturer Received: 03/18/2021
• Initial Date FDA Received: 04/15/2021
• Supplement Dates Manufacturer Received: 06/28/2021
• Supplement Dates FDA Received: 07/28/2021
• 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
• Treatment: BAG VALVE MASK; MAQUET SERVO-I VENTILATION SYSTEM; MAQUET SERVO-I VENTILATION SYSTEM
• Patient Outcome(s): Other
• Patient Age: 62 YR