MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD INFANT OPTIFLOW TUBING KIT; BTT

Model Number RT330

Device Problem Device Handling Problem (3265)

Patient Problem Low Oxygen Saturation (2477)

Event Date 04/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint rt330 has not been returned to fisher & paykel healthcare for evaluation.Our investigation is based on information and photographs provided by the customer.Results: inspection of the photographs revealed that a small section of the complaint inspiratory limb was damaged in the central area of the tubing.The inner and outer tubes had melted in this section of the limb and several small holes had formed.The heater wire insulation appeared undamaged, indicating that the heater wire had not produced excessive heat.The pitch of the heater wire was uniform, with no abnormalities.The appearance of the tubing suggested that it may have been covered or under compressive load for a considerable length of time.A simulation test using a known good rt330 circuit had been undertaken and involved covering a section of the limb with four layers of cloth and connecting it to an mr850 humidifier at a flow of 1lpm.The test was performed for 2.5 hours.Following this testing, the resistance test showed that the inspiratory heater wire was within specification.During simulated testing the production sample rt330 inspiratory limb did not overheat and no melting was observed.In all our simulations we were unable to replicate the damage observed on the returned rt330 infant breathing circuit.The hospital further reported that the mr850 respiratory humidifier included in the setup at the time of the reported incident was checked and found to be functioning correctly.The mr850 contunues to be used by the hospital.Conclusion: we are unable to determine the cause of the observed damage on the returned rt330 infant breathing circuit.Our testing indicated that even covering the circuit for long periods of time would not result in any overheating or melting of the rt330 circuit.All breathing circuits are pressure and leak tested prior to being released for distribution.Any circuits that fail are rejected.The user instructions that accompany the rt330 include the following statements: - check all connections, caps and/or plugs are tight before use.- do not cover the circuit with material such as blankets, towels or bed linen.

Event Description

A hospital in (b)(6) reported that a patient was using an rt330 infant optiflow circuit with an mr850 humidifier.They stated that the mr850 had alarmed frequently for low temperature during that day.At 10:30pm that night the patient was desaturating.Hospital staff then removed the optiflow system and administered oxygen from another source and the patient was well saturated again.They then discovered that the circuit had "melted and there was a hole".There was no further patient consequence.

• Brand Name: INFANT OPTIFLOW TUBING KIT
• Type of Device: BTT
• 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: faranak gomarooni ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 7485881
• MDR Text Key: 107721087
• Report Number: 9611451-2018-00344
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K020332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/06/2018

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: RT330
• Device Catalogue Number: RT330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/06/2018
• Initial Date FDA Received: 05/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Weight: 5