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

Model Number RT380

Device Problem Physical Property Issue (3008)

Patient Problem No Patient Involvement (2645)

Event Date 08/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint rt380 adult dual heated evaqua2 breathing circuit was returned to fph in (b)(4) for inspection.It was visually inspected and electrical resistance tested using a calibrated multimeter.Results: visual inspection revealed that the evaqua2 expiratory limb was degraded and brittle.The inspiratory limb was found to have a loose elbow connector.The electrical resistance test revealed that the inspiratory heaterwire was out of specification.No fault was found with the expiratory heaterwire.Continuity testing and visual inspection revealed that the open circuit in the inspiratory heaterwire was due to a break in the connection between the heaterwire and the left heaterwire pin inside the overmoulded plug.The heaterwire plug as also found to be partly melted.A lot check was not performed as lot information was not provided.Conclusion: it is most likely that the affected breathing circuit came into contact with a chemical solution, which resulted in the degradation of the evaqua2 expiratory limb.We were unable to determine what has caused the elbow connector in the inspiratory limb to become loose.However, based on the previous investigations on similar complaints, such fault usually occur when a breathing circuit is cleaned and reused.Electrical open circuits in heaterwires can be associated with improper crimping of the heaterwire during production, such that it is unable to provide continuity for the full period of use.All breathing circuits are visually inspected and electrically tested during production and those that fail are rejected.This suggests that the subject breathing circuit became damaged after it was released for distribution.Our user instructions that accompany the rt380 adult dual heated evaqua2 breathing circuit state the following: "do not soak, wash, sterilize or reuse this product.Avoid contact with chemicals, cleaning agents or hand sanitizers." "reuse may result in transmission of infectious substances, interruption to treatment, serious harm or death." "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 to a fisher & paykel healthcare (fph) field representative that the temperature did not rise when the heater wire adaptor was connected to an rt380 adult dual heated evaqua2 breathing circuit and an mr850 respiratory humidifier.The humidifier eventually generated a heaterwire disconnect alarm.When the subject breathing circuit was replaced with a new unit, the humidification system functioned as intended.This was observed before use on a patient.

• Brand Name: ADULT 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: raymond yan ; 173 technology dr., suite 100; irvine; 9494534000
• MDR Report Key: 6016033
• MDR Text Key: 56988056
• Report Number: 9611451-2016-00649
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K122432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/22/2016

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: RT380
• Device Catalogue Number: RT380
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2016
• Initial Date Manufacturer Received: 08/22/2016
• Initial Date FDA Received: 10/10/2016
• 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
• Treatment: MR850 RESPIRATORY HUMIDIFIER