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

Model Number RT235

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2014

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported via our distributor that the expiratory limbs of two rt235 infant dual-heated evaqua breathing circuits were found damaged during use.No patient consequence was reported.

Manufacturer Narrative

(b)(4).One of the complaint breathing circuits is currently en route to fisher & paykel healthcare for evaluation.We will provide a follow up report upon completion of our investigation.

Manufacturer Narrative

(b)(4).Method: one of the complaint rt235 infant evaqua breathing circuits was received at fisher & paykel healthcare in (b)(4) for evaluation.The complaint breathing circuit was visually inspected and pressure tested.Results: visual inspection of the evaqua expiratory limb revealed a 3mm x 4mm hole approximately 115mm from the patient end connector.The pressure test result was outside of the specification.A lot check revealed no other complaints for lot number 140417.Conclusion: we were unable to determine how the expiratory limb came to be damaged, but based on our visual inspection the limb appeared to have been punctured by a blunt object.All rt235 breathing circuits are visually inspected and pressure tested for leaks before releasing for distribution and any circuit that fails is discarded.In addition, tube weighing and bond strength testing are performed every 15 minutes; if this test detects a fault, the whole batch is placed on hold for investigation.This suggests that the subject breathing circuit was damaged after it was released for distribution.The key difference between the evaqua breathing circuits and conventional breathing circuits is that the expiratory tube of evaqua circuits such as the rt235 is composed of a thin, semi-permeable film specially designed to allow water vapour from expired ventilatory gas to pass through.The evaqua expiratory tube has a protective mesh which prevents damage to the walls of the tube, however the evaqua tubing can be susceptible to damage when exposed to excessive rough handling or damage caused by blunt or sharp objects and non-fph circuit hangers.The user instructions supplied with the rt235 infant evaqua breathing circuit state: "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." "use caution when positioning the circuit.Sharp or harsh edges and surfaces may damage the expiratory limb." "set appropriate ventilator alarms.".

Event Description

A hospital in (b)(6) reported via our distributor that the expiratory limbs of two rt235 infant dual-heated evaqua breathing circuits were found damaged during use.No patient consequence was reported.

• Brand Name: INFANT DUAL-HEATED EVAQUA 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: raymond yan ; 15365 barranca parkway; irvine, CA 92618-2216
• MDR Report Key: 4342343
• MDR Text Key: 19347487
• Report Number: 9611451-2014-00923
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K034026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT235
• Device Catalogue Number: RT235
• Device Lot Number: 140417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/28/2014
• Initial Date FDA Received: 12/18/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2014
• 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