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

Model Number RT330

Device Problem Device Issue (2379)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint rt330 infant optiflow circuit was received at fisher & paykel healthcare (fph) in (b)(4) for evaluation.The rt330 circuit was visually inspected and electrically tested.Result: visual inspection revealed that there was no damage to the circuit.The electrical testing revealed that the heater wire resistance of the circuit was within specification.Conclusion: the rt330 has not caused or contributed to the event.The hospital confirmed that the incubator lid was open for a considerable period of time for a longline procedure and when the incubator lid was closed water came out of the prongs and into the nares of the baby.A nurse monitoring the baby after the incident noticed that the baby was stable and discontinued the high flow therapy.It is likely that the condensation entered the baby's airpath as a result of the lid of the incubator being open for a lengthy period, allowing the incubator to cool.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 rt330 include the following statements: attention: - patient monitoring is recommended.Warning: - when mounting a humidifier adjacent to a patient ensure that the humidifier is always positioned lower than the patient.

Event Description

A hospital in (b)(6) reported that an rt330 infant optiflow circuit and optiflow junior 2 nasal cannula were used on a baby.A nurse reported that excessive condensate from the circuit went into the baby via the nasal cannula.No patient consequence was reported.

• 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; 2013 ; NZ 2013
• Manufacturer Contact: sharon kuruvilla ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 7288111
• MDR Text Key: 100786536
• Report Number: 9611451-2018-00131
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K020332
• 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: 01/25/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/25/2018
• Initial Date FDA Received: 02/21/2018
• 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