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

Model Number RT265

Device Problem Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint rt265 infant dual-heated evaqua2 breathing circuit was returned to fisher & paykel healthcare (f&p) in (b)(4) for investigation where it was visually inspected.Results: visual inspection revealed the evaqua2 limb of the complaint breathing circuit to be cut about 10cm from the patient end connector.Conclusions: we are unable to determine the root cause of the reported event, however the tube appeared to be cut.All rt265 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 rt265 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." "reuse may result in transmission of infectious substances, interruption to treatment, serious harm or death." "check all connections are tight before use." "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 distributor in (b)(6) reported on behalf of a healthcare facility via a fisher & paykel healthcare (f&p) field representative that the expiratory limb of a rt265 infant dual-heated evaqua2 breathing circuit was broken after 5 days of use.There was no patient consequence.

• Brand Name: INFANT 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
• MDR Report Key: 9914177
• MDR Text Key: 187895673
• Report Number: 9611451-2020-00341
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT265
• Device Catalogue Number: RT265
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Date Manufacturer Received: 03/04/2020
• 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