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

Model Number RT268

Device Problem Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 complaint rt268 circuit's expiratory limb was received and was visually inspected.Results: the evaqua2 limb had degraded.The degradation is most likely caused by the nebulizing alevaire (tyloxapol) agent that the customer had used.In addition, excessive use of the circuit for 10 days may have also contributed to the damage.Conclusion: the rt268 infant dual heated evaqua2 breathing circuit is a single use device that is intended to be used for a maximum of seven days.Furthermore, the user instructions that accompany the rt268 state: -"this product is intended to be used for a maximum of 7 days." -"do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, clenaing agents, or hand sanitizers." -"reuse may result in transmission of infectious substances, interruption to treatment, serious harm or death." - do not use medications containing tyloxapol (such as tacholiquin) as this may damage the tubing and lead to a loss of ventilation pressure.

Event Description

A hospital in (b)(4) reported to a fisher & paykel healthcare (fph) field representative that the expiratory limb of an rt268 infant dual heated evaqua2 breathing circuit separated around the collar during 10 days of use.They were using a bosmin and an alevaire (tyloxapol) with nebulizer for the patient.No patient harm was reported as a result of this incident.

• 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 drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 7269151
• MDR Text Key: 100184992
• Report Number: 9611451-2018-00116
• 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: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2018
• 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