MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX FILTERED HME SYSTEMS; FILTER, BACTERIAL, BREATHING-CIRCUIT

Model Number	62.002.0090.9064/711CRSA
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This remediation mdr was generated under protocol b10010116, as a result of warning letter cms#617147.The product was discarded.No product sample was received; therefore, visual and functional testing could not be performed.However, photographs were taken, but have not been submitted at this time for review/investigation.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.
Event or Problem Description
It was reported that the patient had difficulty upon ventilation using the humidification (hme) filter.The medical emergency transport (met) was called, and the patient was reopened and had an icu admission.The product was disposed/discarded of the affected hme.There was no injury, or medical intervention provided.

• Brand Name: PORTEX FILTERED HME SYSTEMS
• 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 17009830
• Report Number: 3012307300-2023-05700
• Device Sequence Number: 15370799
• Product Code: CAH
• UDI-Device Identifier: 15019315083303
• UDI-Public: 15019315083303
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K033008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 05/26/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 62.002.0090.9064/711CRSA
• Device Catalogue Number: 002823P
• Device Lot Number: LT2008 (100585000)
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male