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

Model Number RT268

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4) pma/510(k) the rt268 infant dual heated evaqua2 breathing circuit is not sold in the usa but it is similar to a product sold in the usa.The 510(k) for that product is k103767.Method: the expiratory limb of the complaint rt268 infant dual heated evaqua2 breathing circuit was returned to fisher and paykel healthcare in (b)(4), and was visually inspected.Results: visual inspection of the returned expiratory limb revealed that it was degraded near the patient end connector.A crack was also observed at the patient end connector's pressure line port.Conclusion: the observed degradation is most likely due to the use of the nebulizing drug alevaire, which contains tyloxapol as an active ingredient.Our user instructions that accompany the rt268 infant dual heated evaqua2 breathing circuit have the warning "do not use medications containing tyloxapol (such as tacholiquin) as this may damage the tubing and lead to a loss of ventilation pressure".It also state the following: "set appropriate ventilator alarms." "perform a pressure and leak test on the breathing system and check for occlusion before connecting to a patient." "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 distributor that the collar of one of the limbs of an rt268 infant dual heated evaqua2 breathing circuit was found cracked after six days of use.It was also reported that alevaire, which contains tyloxapol as an active ingredient, was used; however, it was stopped few days before the reported damage on the limb was observed.No patient consequence was reported.

• Brand Name: INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Type of Device: BZE
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer Contact: sharon kuruvilla ; 173 technology dr., suite 100; irvine; 9494534000
• MDR Report Key: 7372198
• MDR Text Key: 103919558
• Report Number: 9611451-2018-00206
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT268
• Device Catalogue Number: RT268
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2018
• 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