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

Model Number RT265

Device Problems Crack (1135); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2015

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported that the ventilator alarmed and staff noticed that the patient end collar of the expiratory limb of an rt265 infant dual-heated evaqua2 breathing circuit had cracked.The hospital stated that there was no patient consequence.

Manufacturer Narrative

(b)(4).Method: the expiratory limb of the complaint rt265 infant evaqua2 breathing circuit was returned to fisher & paykel healthcare in (b)(4) and was visually inspected.Further information was also sought from the customer but a response was not provided.Results: visual inspection revealed that the proximal connector was cracked and partly detached from the expiratory limb.There was no visible damage noted to the tubing itself.A lot check revealed no other similar complaints for the lot number provided.Conclusion: based on the nature of the observed cracking and previous investigations into this type of failure, the cracking is most likely due to the connectors coming into contact with a cleaning chemical, resulting in environmental stress cracking.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 hospital reported that the damage occurred after a period of use, which suggests that the complaint circuit became damaged after the product was released for distribution.Our user instructions that accompany the rt265 state the following: - 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.The user instructions also state the following: - do not soak, wash, sterilize or reuse this product.Avoid contact with chemicals, cleaning agents or hand sanitizers.

• 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
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: raymond yan ; 15365 barranca parkway; irvine, CA 92618-2216 ; 9494534000
• MDR Report Key: 4767387
• MDR Text Key: 5783434
• Report Number: 9611451-2015-00237
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2015
• 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: 150130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2015
• Date Manufacturer Received: 04/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2015
• 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