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

Model Number RT266

Device Problems Detachment Of Device Component (1104); Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A hospital in (b)(6) , reported via a fisher & paykel healthcare field representative that the swivel wye of an rt266 infant dual-heated evaqua2 breathing circuit "is disconnecting and the cap is popping off." no patient consequence was reported.

Manufacturer Narrative

(b)(4).We are in the process of obtaining the complaint device for evaluation.Our investigation is in progress and we will provide a follow-up report upon completion of our investigation.

Manufacturer Narrative

(b)(4).Method: four rt266 infant breathing circuits (1x lot 141023, manufactured on 23 october 2014; 1x lot 141201, manufactured on 1 december 2014; 2x lot 150203, manufactured on 3 february 2015), three drylines and two swivels were returned to fisher & paykel healthcare in (b)(4) for further investigation.The devices were visually inspected, the circuits and swivels were additionally pressure tested and the drylines were additionally water bath tested to check for leaks.Results: visual inspection revealed no damage to the returned circuits and swivels.The pressure test result revealed that the circuits and returned swivels were within specification.Visual inspection of the three returned drylines revealed that in all three cases the first tube corrugation from the chamber end was damaged and appeared to have been compressed and pinched.There was a pin-sized hole next to the compressed part of the corrugation.Additionally, two of the three drylines had stress marks on the chamber end tube collar.The water bath test showed that all three drylines were leaking from the pin-sized hole in the dryline tubing.A lot check revealed no other complaints of this nature for lot 141023, lot 141201 or lot 150203.Conclusion: we are unable to determine why the swivel wye of an rt266 circuit was "disconnecting and the cap popping off." all swivels were checked for tightness of fit during the pressure testing and no disconnection occured.We are unable to determine what may have caused the pinching of the returned drylines.No fault was found with the returned rt266 infant dual-heated evaqua2 breathing circuits and swivels.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 user instructions that accompany the rt266 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.

Event Description

A hospital in (b)(6), reported via a fisher & paykel healthcare field representative that the swivel wye of an rt266 infant dual-heated evaqua2 breathing circuit "is disconnecting and the cap is popping off." 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: 4636951
• MDR Text Key: 5755297
• Report Number: 9611451-2015-00173
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2015
• 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
• Device Lot Number: 141023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2014
• 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