MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFEHMEF 750/S, DISPOSABLE; FILTER, BACTERIAL, BREATHING-CIRCUIT

Model Number AIRLIFE¿HMEF 750/S, DISPOSABLE

Device Problem Filtration Problem (2941)

Patient Problem Respiratory Failure (2484)

Event Date 10/05/2020

Event Type  Death  

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.Initial device analysis found that the ventilator showed no system error.No exact root cause could be determine at this time since the investigation is still ongoing.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

It was reported to vyaire medical that the ventilator alarms on high pressure, low minute ventilation, set-alarm-undershoot were generated.The doctor discharged the patient from the ventilator and switched to an ambu bag, but the patient passed away 20 minutes later.The customer confirmed that due to the patient's pre-existing health condition, acute exacerbation of pneumoconiosis, he was unable to survive.But the physician believes that the occlusion of hmef played a role in the patient's death.

Manufacturer Narrative

Device history record was reviewed and no abnormalities were discovered.Small percentage of this lot was scrapped due to visual defects and small percentage was also reworked due to defects.These are normal procedures.All hmef products in vincent medical production go through 100% leak and flow resistance testing.Additionally, retention samples from lot# 0207321 were tested for leak and flow resistance and all tests were passed.Complaint sample was decontaminated and received at vyaire helsinki site.Sample was unpacked, visually inspected and tested for flow resistance.It was discovered in visual inspection that the used opa decontamination solution had entered the hme foam and filter.After visual inspection sample was tested for flow resistance with 30l/min flow.As the flow was applied to the sample some of the opa solution came out of the sample.Initial result of the flow resistance test for the sample at 30l/min was 1,874kpa.After some of the opa solution was flushed out of the hmef the flow resistance reading dropped to 0,866kpa.Both of these are clearly heightened flow resistance test results compared to unused product flow resistance which is in the range of ~0,9-1,1kpa which was also evidenced by testing 5 new samples.The higher flow resistance value is logical and expected as the product has been soaked in the decontamination fluid.With the test results no evidence of design or manufacturing defect in the product can be concluded.The performance of the sample product has been impacted by the decontamination method and thus this complaint investigation cannot provide any reliable result for complaint root cause analysis.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: AIRLIFEHMEF 750/S, DISPOSABLE
• Type of Device: FILTER, BACTERIAL, BREATHING-CIRCUIT
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 10766884
• MDR Text Key: 214078351
• Report Number: 3004050971-2020-00009
• Device Sequence Number: 1
• Product Code: CAH
• UDI-Device Identifier: 10885403284151
• UDI-Public: (01)10885403284151(10)0207321
• Combination Product (y/n): N
• PMA/PMN Number: K031653
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/06/2020

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: AIRLIFE¿HMEF 750/S, DISPOSABLE
• Device Catalogue Number: M1004132
• Device Lot Number: 0207321
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/06/2020
• Initial Date FDA Received: 10/30/2020
• Supplement Dates Manufacturer Received: 04/08/2021
• Supplement Dates FDA Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Death