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

Model Number MR290V

Device Problems Crack (1135); Gas/Air Leak (2946)

Patient Problems Low Oxygen Saturation (2477); Respiratory Insufficiency (4462)

Event Date 08/30/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare (f&p) is currently in the process of obtaining additional information with regards to the reported event.We have also requested the subject mr290v vented autofeed humidification chamber to be returned to f&p (b)(4) for investigation.We will provide a follow-up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported that a mr290v vented autofeed humidification chamber was leaking during use on a patient.The patient was provided an alternative form of ventilation via manual bagging while the circuit and chamber was replaced.It was further reported that the patient did not tolerate alternative bag ventilation and went into "respiratory crisis".No further patient consequences were reported.

Event Description

A healthcare facility in united kingdom reported that a mr290v vented autofeed humidification chamber was leaking air during use on a patient.The patient was provided an alternative form of ventilation via manual bagging while the non f&p breathing circuit and mr290 chamber was replaced.The patient did not tolerate alternative bag ventilation and went into "respiratory crisis" with desaturation to 60%-70% spo2 levels when they were placed on the new set up.The patient was provided "manual breaths" via the ventilator, and thereafter recovered to 94%-97% spo2 levels.It was further reported that the patient deceased eight days following the reported incident and the medical cause of death was bronchopulmonary dysplasia (bpd) related to premature birth.The healthcare facility also confirmed that the patient death was expected and not related to the incident.

Manufacturer Narrative

(b)(4).Method: the mr290v vented autofeed humidification chamber was returned to fisher & paykel healthcare (f&p) in new zealand where it was visually inspected and analysed.Results: visual inspection of the returned mr290v chamber revealed a horizontal crack line on the chamber dome below the maximum water line.It was also observed that there were smudge marks on the chamber dome near the location of the chamber crack indicating that the chamber was in contact with a solution containing alcohol.Further thermoanalytical testing also revealed that the chamber dome showed extensive gouging/scuffing near the fracture point of the chamber crack which is consistent with externally applied forces causing the stress damage.Conclusion: we are unable to determine the root cause of the chamber crack, however our investigation indicates that the crack is most likely due to mechanical stress.The stress source was unable to be identified.It should be noted that based on previous investigations of the mr290v chamber, exposure to alcohol based chemicals may affect the integrity of the chamber dome.This can potentially lead to stress cracking of the chamber dome in combination with externally applied forces.The reported patient respiratory distress occurred while the patient was provided manual bagging with a non-f&p device.The patient further desaturated to 60%-70% spo2 when they were placed on the new set up.The patient was provided "manual breaths" via the ventilator and recovered to 94%-97% spo2.Every mr290 chamber is pressure tested following the manufacturing process to check for any leaks present in the chamber dome due to cracks and other causes.Any chamber which fails this test is rejected.In addition, the pressure test is followed by a visual inspection of each chamber.No cracks in the chamber dome are acceptable.Any chamber that fails this inspection is rejected.The subject mr290v chamber would have met the required specification at the time of production.Our user instructions that accompany the mr290v vented autofeed humidification chamber state the following: - "do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers." - "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient." - "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." - "use of the mr290 above the maximum operating pressure may lead to cracking, water leakage and, on rare occasions, could lead to a loss of ventilation pressure" - "do not use the chamber if the seals are not intact when received, or if it has been dropped." -"the use of breathing circuits, chambers, accessories, or combinations which are not approved by fisher & paykel healthcare may result in poor humidification system performance, ventilator malfunction, and harm to the patient/ user".

• Brand Name: VENTED AUTOFEED HUMIDIFICATION CHAMBER
• Type of Device: AUTOFEED CHAMBER
• 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 dr.; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 12637403
• MDR Text Key: 279006175
• Report Number: 9611451-2021-01180
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K934140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/17/2021

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: MR290V
• Device Catalogue Number: MR290V
• Device Lot Number: 2008292238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/17/2021
• Initial Date FDA Received: 10/14/2021
• Supplement Dates Manufacturer Received: 12/16/2021
• Supplement Dates FDA Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2020
• 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: GETINGE BREATHING CIRCUIT