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

Model Number RT266

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: two complaint rt266 infant dual heated evaqua2 breathing circuits were returned to fisher & paykel healthcare in (b)(4) for evaluation.The circuits were visually inspected and pressure tested.Results: visual inspection revealed that the collar at the patient end of one of the two circuits, at the expiratory limb, was cracked.Pin holes were observed in the inspiratory limb, approximately 620 mm from the chamber end connector.The pressure test revealed that this circuit was out of specification.There was no visible damage found to the other circuit.Pressure test revealed that the returned breathing circuit was within specification and did not exhibit excessive leak.A lot check was not performed as lot information was not 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 connector coming into contact with a cleaning chemical, resulting in environmental stress cracking.However, we were unable to determine definitively the root cause of the observed pin holes in the inspiratory limb.All rt266 infant dual heated evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The healthcare facility reported that the damage was noticed while the patient was setup with the circuit, which suggests that the subject breathing circuit became damaged after the product was released for distribution.Our user instructions that accompany the rt266 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 occlusions before connecting to a patient." - "set appropriate ventilator alarms." - "do not soak, wash, sterilize or reuse this product.Avoid contact with chemicals, cleaning agents or hand sanitizers.".

Event Description

A hospital in (b)(6) reported to a fisher & paykel healthcare field representative that holes were found in the tubing of six rt380 adult dual heated evaqua2 breathing circuits.This was observed while the patient was setup with the circuit.No patient consequence was reported.

• 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: 5113839
• MDR Text Key: 27257574
• Report Number: 9611451-2015-00422
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Report Date: 08/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT266
• Device Catalogue Number: RT266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2015
• 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