MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD INFANT CONTINUOUS FLOW BREATHING CIRCUIT; BTT

Model Number RT132

Device Problem Infusion or Flow Problem (2964)

Patient Problem Low Oxygen Saturation (2477)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint rt132 infant continuous flow breathing circuit was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information provided by the customer and the knowledge of our product.Results: the customer stated that the pressure line of a rt132 infant continuous breathing circuit became disconnected from the ventilator during cpap therapy on a patient.The patient desaturated to 86% spo2 and was provided alternative therapy using a rd900 neopuff infant resuscitator.The patient's condition improved to 90% spo2.It was also reported that the patient was intubated and placed on a ventilator for 13 hours.It was further reported that the patient recovered to a stable condition.No further patient consequences was reported.Conclusion: without the return of the complaint device, we are unable to determine what may have caused the reported event.All rt132 infant continuous flow breathing circuits are visually inspected and pressure tested prior to being released for distribution, and those that fail are rejected.The subject rt132 infant continuous flow breathing circuit would have met the required specifications at the time of production.The user instructions that accompany the rt132 infant continuous flow breathing circuit states: "check all connections are tight before use." "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." " ensure approptiate ventilator or flow source alarms are set before connecting breathing set to patient." "failure to comply with any of the following warnings may impair performance of the device or compromise safety (including potentially causing serious harm).".

Event Description

A healthcare facility in the (b)(6) reported, via a fisher and paykel field representative that the pressure line of a rt132 infant continuous breathing circuit became disconnected from the ventilator during cpap therapy on a patient.The patient desaturated to 86% spo2 and was provided alternative therapy using a rd900 neopuff infant resuscitator.The patient's condition improved to 90% spo2.It was also reported that the patient was intubated and placed on a ventilator for 13 hours.It was further reported that the patient recovered to a stable condition.No further patient consequences was reported.

• Brand Name: INFANT CONTINUOUS FLOW BREATHING CIRCUIT
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 12164441
• MDR Text Key: 261423084
• Report Number: 9611451-2021-00804
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K020332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 06/14/2021

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: RT132
• Device Catalogue Number: RT132
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/14/2021
• Initial Date FDA Received: 07/14/2021
• 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
• Treatment: RD900 NEOPUFF INFANT RESUSCITATOR; VIASYS INFANT FLOW SIPAP VENTILATION SYSTEM