MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED VENTED AUTOFEED HUMIDIFICATION CHAMBER; BTT

Model Number MR290V

Device Problem No Flow (2991)

Patient Problem Cardiac Arrest (1762)

Event Date 01/21/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The hospital reported that the complaint mr290v vented autofeed humidification chamber was discarded at their facility.We are currently in the process of obtaining further information from the hospital to determine if the complaint mr290v vented autofeed humidification chamber and the use of the wilamed pmh5000 humidifier, which is a non-fph humidifier, caused or contributed to the reported adverse event.We will provide a follow up report once we have completed our analysis.

Event Description

A hospital in (b)(6) reported to a fisher & paykel healthcare (fph) field representative that a nurse noticed that there was no water inside an mr290v vented autofeed humidification chamber while it was being used on a patient, who was on a ventilator support at that time.It was also reported that the patient allegedly had respiratory distress due to dry secretions, and a total atelectasis of one lung and partly on the other lung.This, according to the hospital staff, had allegedly led to cardiac arrest.The subject mr290v chamber was used in conjunction with an rt265 infant dual heated evaqua2 breathing circuit, drager v500 ventilator, and wilamed pmh5000 humidifier.It was also mentioned that the water bag was positioned 47cm above the subject chamber.The complaint mr290v chamber was discarded at the hospital facility.Additional information received from the hospital revealed that the patient did not suffer any damage and is currently in stable condition "without further worsening of respiratory status".

Manufacturer Narrative

(b)(4).The complaint mr290v vented autofeed humidification chamber was not returned to fph as it was discarded at the hospital's facility.Our analysis is accordingly based on the additional information that we received from the hospital and our knowledge of the product.The hospital reported that the subject mr290v chamber was not filling up with water while it was being used on patient, who was also on a ventilator support at that time.Additional information received from the hospital revealed that such issue was also allegedly observed in two other incidents with the same patient, involving two other mr290v chambers.All complaint mr290v chambers were included in the rt265 infant dual heated evaqua2 breathing circuit kits.In the first two incidents, the mr290v chambers were used with a non-fph humidifier.In the last incident, the mr290v chamber was used with the fph humidifier and small amount of moisture was observed inside the chamber.No alarm was reportedly observed during these incidents.The hospital staff also stated that the water bag was positioned 47cm above the complaint mr290v chamber.Without the complaint mr290v chambers, we are unable to confirm the fault reported by the hospital and determine its root cause.It is recommended in the user instructions of the rt265 infant dual heated evaqua2 breathing circuit to use the fph mr850 respiratory humidifier, which gives a 'water out' indicator alarm in the event that there is insufficient amount of water inside the mr290v chamber.Our user instructions that accompany the rt265 infant dual heated evaqua2 breathing circuit indicate in pictorial form the correct set-up and proper use of the breathing system, including that the mr290v chamber should be at least 50cm below positioned the water bag.It also state the following: "compatible with mr850 humidifiers."; "set appropriate ventilator alarms"; "ensure there is a water supply connected to the chamber and that water is present within the chamber."; "the use of circuit/chamber combinations not recommended by fisher & paykel healthcare may result in poor humidification system performance, ventilator malfunction, and harm to the patient/user".The hospital staff has confirmed that the patient did not suffer any damage and is currently in stable condition "without further worsening of respiratory status".It was also confirmed by the fph field representative that the hospital staff had previously received training on the correct set-up and proper use of the fph humidification system, including the rt265 infant dual heated evaqua2 breathing circuit and the mr290v vented autofeed humidification chamber.

Event Description

A hospital in (b)(6) reported to a fisher & paykel healthcare (fph) field representative that a nurse allegedly noticed that there was no water inside an mr290v vented autofeed humidification chamber while it was being used on a patient, who was on a ventilator support at that time.It was also reported that the patient allegedly had respiratory distress due to dry secretions, and a total atelectasis of one lung and partly on the other lung.This, according to the hospital staff, had allegedly led to cardiac arrest.The subject mr290v chamber was used in conjunction with an rt265 infant dual heated evaqua2 breathing circuit, dräger v500 ventilator, and wilamed pmh5000 humidifier.It was also mentioned that the water bag was positioned 47cm above the subject chamber.The complaint mr290v chamber was discarded at the hospital facility.Additional information received from the hospital revealed that the patient did not suffer any damage and is currently in stable condition "without further worsening of respiratory status".

• Brand Name: VENTED AUTOFEED HUMIDIFICATION CHAMBER
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer Contact: raymond yan ; 15365 barranca parkway; irvine; 9494534000
• MDR Report Key: 5446325
• MDR Text Key: 38513619
• Report Number: 9611451-2016-00056
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K934140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 01/22/2016

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: MR290V
• Device Catalogue Number: MR290V
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/22/2016
• Initial Date FDA Received: 02/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/18/2016
• 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 Outcome(s): Other