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

Model Number RT265

Device Problem Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint rt265 infant evaqua2 breathing circuit is currently en route to fisher & paykel healthcare in (b)(4).We will provide a follow up report upon completion of our investigation.

Event Description

A hospital in the (b)(6) reported that the expiratory limb of the rt265 infant breathing circuit was "discoloured, hard and crumbling".There was no patient consequence.

Manufacturer Narrative

(b)(4).Method: two complaint rt265 circuits were returned to fisher & paykel healthcare (f&p) in new zealand and were visually inspected.Results: visual inspection showed that both expiratory limbs were degraded and brittle.The degraded and brittle areas were found along the length of both limbs and yellowish in colour.The hospital provided additional information that "the rt265 breathing circuits are decanted from cardboard f&p box to a plastic drawer on a shelf which is located in front of a large window".Conclusion: it is known that the tubes can become brittle if they are in prolonged contact with chemicals or are exposed to excessive uv light for a long period of time.The user instructions that accompany the rt265 infant dual heated evaqua2 breathing circuit state the following: - check all connections are tight before use.- perform a pressure and leak test on the breathing system and check for occlusion before connecting to a patient.- set appropriate ventilator alarms.

Event Description

A hospital in the uk reported that the expiratory limb of the rt265 infant breathing circuit was "discoloured, hard and crumbling".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: 7394953
• MDR Text Key: 104541041
• Report Number: 9611451-2018-00262
• 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: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• 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: 2100121579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1