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

Catalog Number C1038J

Device Problem Gas/Air Leak (2946)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2023

Event Type  malfunction  

Event Description

It was reported, that during the pre-use check.Leakage of air from the product was observed.No adverse patient effects were reported by the customer.

Manufacturer Narrative

B3: month and year of event have been provided.Day is unknown.D4: udi section, expiration date and h4: manufacture date are not available based on the reported lot number.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.

Manufacturer Narrative

Device evaluation: one pump device was returned to manufacturing for investigation.Visual inspection and functional testing were performed.Visual inspection of the returned device confirmed that both tamper seals were broken upon receipt.The top case was cracked by the handle and tubing guides with chipped corners.The bottom case was cracked by the l-bracket.The power cord was falling apart.Both plunger cases were chipped.An error code was found in the event history log (ehl).An occlusion test was performed, and the motor assembly was visually inspected.The customer reported issue was confirmed, a motor rate error was duplicated during the test.The root cause of the reported issue is due to normal wear of the motor assembly, the parts were old, dirty, and worn out.The worn parts are ten years old.To correct the issue, the stepper motor, old blue worm gear, worm coupling and motor mount were replaced.Also, the lead screw and both clutch halves were replaced as a preventive measure.Performed power up process, preventive maintenance, occlusion test and all functional tests which passed.The product is beyond a year from manufacture date and there was no indication of a manufacturing defect during the investigation, so a device history record (dhr) review was not performed.Service history review identified this device has not been in for service previously.This remediation mdr was generated under protocol (b)(4) as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX ANESTHESIA BREATHING SINGLE LIMB 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: 16864153
• MDR Text Key: 314862265
• Report Number: 3012307300-2023-05004
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C1038J
• Device Lot Number: 4334832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/19/2023
• Initial Date FDA Received: 05/03/2023
• Supplement Dates Manufacturer Received: 06/19/2023
• Supplement Dates FDA Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1