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

Model Number RT380

Device Problem Moisture or Humidity Problem (2986)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Type  malfunction  

Event Description

A hospital in (b)(4) reported to a fisher & paykel healthcare (fph) representative that they noticed condensation in the expiratory limb of an rt380 adult dual heated evaqua2 breathing circuit.This was found after 48 hours of use.Upon changing the breathing circuit to another rt380 they continued to experience more than usual condensation.The hospital also reported that the patient experienced arrhythmias and hypertension.

Manufacturer Narrative

(b)(4).Since the reported incident an fph representative has been in contact with the hospital.Furhtermore, the complaint devices are currently en route to fisher & paykel healthcare in (b)(4) for evaluation.We will provide a follow up report upon completion of our investigation.

Manufacturer Narrative

(b)(4).Returned devices: 1 x rt380 lot 1309010301 date of manufacture: 1 september 2013, 1 x rt380 lot 1305220301 date of manufacture: 22 may 2013.Method: two rt380 adult dual heated evaqua2 breathing circuits from the same lots as the complaint devices were returned to fph in new zealand for investigation.Both circuits were unopened and were returned in sealed bags.The inspiratory and expiratory heater wires for both circuits were resistance tested using a calibrated multimeter.Results: resistance test revealed that the inspiratory and expiratory heater wires on both of the returned circuits were within specification.A lot check revealed no other complaints of this nature for lots 130901 & 130522.Conclusion: we are unable to determine what may have caused the reported incident.Since the reported event, an fph representative has been working with the hospital staff to address the reported condensation issue.After the fph rep visited the hospital reported that they have not had any further issues regarding condensation.Condensate in the humidification system, is an expected side effect of heated pass-over humidification systems in many conditions, and may vary between light misting to water droplets that form on the wall of cool breathing circuit tubing.The amount of condensate in the ventilation system is influenced by a number of multiple setup and environmental factors.The user instructions that accompany the rt380 state the following: -"set appropriate ventilator alarms".-"check breathing circuits for condensation every 6 hours and drain if required.".

Event Description

A hospital in (b)(6) reported to a fisher & paykel healthcare (fph) representative that they noticed condensation in the expiratory limb of an rt380 adult dual heated evaqua2 breathing circuit.This was found after 48 hours of use.Upon changing the breathing circuit to another rt380 they continued to experience more than usual condensation.The hospital also reported that the patient experienced arrhythmias and hypertension.

• Brand Name: ADULT 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: 4137256
• MDR Text Key: 4910621
• Report Number: 9611451-2014-00793
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K122432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2014
• 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: 1305220301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2013
• 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