MAUDE Adverse Event Report: RESMED LTD ACUCARE HFNC - MEDIUM; CANNULA, NASAL, OXYGEN

Model Number 23007

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

Patient Problem Low Oxygen Saturation (2477)

Event Date 07/03/2023

Event Type  Injury  

Manufacturer Narrative

The device was returned to resmed for an investigation.The investigation methods, results, and conclusion are not finalized at this stage.If more information becomes available, a supplemental report will be submitted.The acucare hfnc user guide provide the following warning:- ¿single patient reuse only.Maximum 7 days reuse in the hospital/clinical environment, 30 days reuse in the home environment if cleaning instructions are followed.¿ the acucare hfnc user guide provides the following warnings: - - ¿do not reuse.- do not use if components are damaged.- before connecting the nasal cannula, check for adequate gas flow, oxygen and temperature.- do not crush or stretch tubing.¿ resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference#: (b)(6) h3 other text : device received; investigation pending.

Event Description

It was reported to resmed that a patient using an acucare high flow nasal cannula (hfnc) experienced desaturation of oxygen.It was reported that while travelling home in an ambulance from the hospital, the patient¿s oxygen saturation dropped to 80%, device displayed a high leak alarm and the hose of the hfnc was allegedly cracked and leaking.Patient returned to the hospital and subsequently expired.

Event Description

It was reported to resmed that a patient using an acucare high flow nasal cannula (hfnc) experienced desaturation of oxygen.It was reported that while travelling home in an ambulance from the hospital, the patient¿s oxygen saturation dropped to 80%, and the hose of the hfnc was allegedly cracked and leaking.Patient returned to the hospital and subsequently expired.

Manufacturer Narrative

The acucare hfnc was returned to resmed and an engineering investigation has been performed.Visual inspection confirmed a tear in the tubing film at the connection to the cannula.Based on the available information and resmed¿s internal investigation, physical abuse (tensile overloading) of the tubing film resulted in tearing of the device tubing.The acucare hfnc was within specification.There is insufficient evidence to suggest that the tear in the device had directly caused the reported patient death.There is no evidence to suggest a deviation in the manufacturing quality of the product.It was reported to resmed that the subject device was used in the hospital for approximately 2 weeks prior to the date of the incident.Acucare hfnc user guide states ¿the acucare hfnc is for single-patient use (maximum 7 days) in the hospital/clinical environment.¿ therefore, the cannula was used outside of its intended use of a maximum 7 days.Acucare hfnc user guide provides the following indications for use: ¿the acucare hfnc is intended for use in patients with acute respiratory failure or non-acute spontaneously breathing patients in the hospital/clinical environment, or for non-acute spontaneously breathing patients in the home.¿ acucare hfnc user guide provides the following warnings: ¿do not use if components are damaged.¿ ¿before connecting the nasal cannula, check for adequate gas flow, oxygen and temperature.¿ ¿do not crush or stretch tubing.¿ resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference#: (b)(4).

• Brand Name: ACUCARE HFNC - MEDIUM
• Type of Device: CANNULA, NASAL, OXYGEN
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer (Section G): RESMED PTY LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer Contact: michelle hughes ; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 17928226
• MDR Text Key: 325565342
• Report Number: 3004604967-2023-00567
• Device Sequence Number: 1
• Product Code: CAT
• UDI-Device Identifier: 00619498230075
• UDI-Public: (01)00619498230075(10)1618934
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133868
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 23007
• Device Catalogue Number: 23007
• Device Lot Number: 1618934
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/28/2023
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Death