MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number C45101796D-NL

Device Problems Break (1069); Moisture Damage (1405); Obstruction of Flow (2423); Moisture or Humidity Problem (2986); Output Problem (3005)

Patient Problems Pulmonary Hypertension (4460); Respiratory Insufficiency (4462)

Event Type  malfunction  

Manufacturer Narrative

Date of event; lot number, expiration date, udi number and device manufacture date is unknown, no information has been provided to date.G5: 510k is blank device is exempt.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that the customer had issues with these anesthesia circuits that are currently in their circulation.Some have had cracks in the corrugated tubing itself, and some had issues with the dime-sized filter in the circuit.The filter gets soaked with moisture and the thick sponge within the filter gets water-logged and prevents medical staff from ventilating the patient.A patient with pulmonary hypertension for ankle surgery that suddenly stopped being ventilated due to the filter issue.

Manufacturer Narrative

Other text: h6 codes updated.No device was returned for investigation, no root cause determined.No lot number was provided, devcie history review not completed.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: PORTEX ANESTHESIA BREATHING CIRCUIT
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• 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: 16722291
• MDR Text Key: 313119834
• Report Number: 3012307300-2023-03969
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C45101796D-NL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1