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

Model Number 62.002.0090.9064/711CRSA

Device Problem Difficult to Insert (1316)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/20/2022

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 316010217
• Report Number: 3012307300-2023-05700
• Device Sequence Number: 1
• Product Code: CAH
• UDI-Device Identifier: 15019315083303
• UDI-Public: 15019315083303
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K033008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male