MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; PORTEX RESPIRATORY FILTERS HEPA

Model Number PORTEX 150-1500ML

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2020

Event Type  malfunction  

Event Description

Information received a smiths medical breathing|portex respiratory filters hepa malfunctioned during an operation.The customer used the product from 9:00 to 17:30 for the operation, during which intravenous anesthesia was given to the patient at flow rate of 3 liters per minute.Some water droplets were seen in the filter when he visually checked it during the operation.However, after the operation, respiratory resistance rose.So he replaced the product with another one.No patient injury.

• Brand Name: PORTEX
• Type of Device: PORTEX RESPIRATORY FILTERS HEPA
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: david halverson ; 6000 nathan lane north; 2jo kudaru, kawaharamachidori,; minneapolis, MN 55442
• MDR Report Key: 10402395
• MDR Text Key: 202742927
• Report Number: 3012307300-2020-08158
• Device Sequence Number: 1
• Product Code: CAH
• UDI-Device Identifier: 15019315083297
• UDI-Public: 15019315083297
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K033008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/13/2020

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: No Information
• Device Model Number: PORTEX 150-1500ML
• Device Catalogue Number: 2874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/14/2020
• Initial Date FDA Received: 08/13/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1