MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD MANUAL FILL INFANT/PAEDIATRIC HUMIDIFICATION CHAMBER; BTT

Model Number MR225

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Bradycardia (1751); Low Oxygen Saturation (2477)

Event Date 06/25/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).We are currently in the process of obtaining further information relating to the incident from the healthcare facility.We will provide a follow-up report upon completion of the investigation.

Event Description

It was reported to fisher & paykel healthcare via (b)(6) that a (b)(6) day-old child, born prematurely at (b)(6) weeks, was undergoing non-invasive ventilation therapy.When the fisher & paykel healthcare mr225 humidification chamber was being used, the valve of the device was improperly closed.As a result, the water exceeded the maximum limit and was forced back into the inspiratory limb of the breathing circuit which ended up in the child's upper airways.The patient suffered bradycardia (55/60bpm) and their saturation level dropped to around 20-30%.An insufflator balloon with nasal and oral aspiration was implemented and the patient heart rate recovered to be more than 130 bpm and with a saturation level of more than 85% after 1 minute of intervention.No further patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: the complaint mr225 humidification chamber was not returned to fisher & paykel healthcare (f&p) for evaluation.No further information was received for our questions.Our investigation is based on the information provided by the customer and our knowledge of the product only.Results: the customer stated that the mr225 humidification chamber overfilled because the valve of a water feed set assembly that was used with the device, was improperly closed.Conclusion: without the return of the complaint device and further information, we are unable to determine the root cause of the reported fault.Mr225 is a manually filled chamber and the water level is to be controlled by the operator or user.The chamber itself does not have a "valve".The valve will be typically associated with a water feed set assembly used with a manual chamber.No device or product information has been supplied for the water feed set assembly or the valve used with it.Thus it is unclear what "valve" was not properly closed and caused chamber to overfill.The user instruction that accompany the mr225 humidification chamber specify in the warning section: do not fill the chamber above the maximum fill level line.Liquid could enter the breathing circuit if the chamber is overfilled.Ensure that the water level in the chamber is periodically monitored.Refill when necessary.

Event Description

It was reported to fisher & paykel healthcare via (b)(6) that a 15 day-old child, born prematurely at 25 weeks, was undergoing non-invasive ventilation therapy.When the fisher & paykel healthcare mr225 humidification chamber was being used, the valve of the device was improperly closed.As a result, the water exceeded the maximum limit and was forced back into the inspiratory limb of the breathing circuit which ended up in the child's upper airways.The patient suffered bradycardia (55/60bpm) and their saturation level dropped to around 20-30%.An insufflator balloon with nasal and oral aspiration was implemented and the patient heart rate recovered to be more than 130 bpm and with a saturation level of more than 85% after 1 minute of intervention.No further patient consequence was reported.

• Brand Name: MANUAL FILL INFANT/PAEDIATRIC HUMIDIFICATION CHAMBER
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 8853717
• MDR Text Key: 175208553
• Report Number: 9611451-2019-00755
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K913367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MR225
• Device Catalogue Number: MR225
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/03/2019
• Initial Date FDA Received: 08/01/2019
• Supplement Dates Manufacturer Received: 08/23/2019
• Supplement Dates FDA Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 15 DA