MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX HEAT AND MOISTURE EXCHANGE FILTER, ELECTROS; FILTER, BACTERIAL, BREATHING-CIRCUIT

Model Number	62.002.0090.9064/711CRSA
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Death
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.
Event or Problem Description
It was reported that "an accident occurred when this product was used in combination with a humidifier." the product was used in combination with a heating humidifier and a medical incident occurred during the use of it.This is an investigative inquiry from the police in the jurisdictional area, and details are unknown.Pre-use check was not clear.Disinfection and sterilization status were unknown.The following additional information was provided on (b)(6) 2022: the patient was in their 70s and had a tracheotomy tube.Also, the patient was using a heating humidifier under the control of an artificial respirator.After the patient took a bath, the breathing circuit was re-connected, and then, the healthcare worker left the patient's side.After that, the patient was found dead in the hospital room.The healthcare worker noticed an hme filter was attached to the breathing circuit, which had not been used before bathing.The cause of death is unknown.
Additional Manufacturer Narrative
Other, other text: no lot number was provided; therefore, device history record review could not be performed.No product sample was received and there was no evidence showing the defect; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If evidence is made available, the investigation will be reopened., corrected data: d4: device lot number is unknown.
Additional Manufacturer Narrative
Other, other text: corrected data h1, corrected data: corrected data h1 death.

• Brand Name: PORTEX HEAT AND MOISTURE EXCHANGE FILTER, ELECTROS
• Common Device Name: FILTER, BACTERIAL, BREATHING-CIRCUIT
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15748167
• Report Number: 3012307300-2022-26832
• Device Sequence Number: 12322581
• Product Code: CAH
• UDI-Device Identifier: 15019315083303
• UDI-Public: 15019315083303
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K033008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/29/2023

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
• Operator of Device: Health Professional
• Device Model Number: 62.002.0090.9064/711CRSA
• Device Catalogue Number: 002823P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/13/2022
• Supplement Date Received by Manufacturer: 11/07/2022; 06/28/2023
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 11/10/2022; 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown