MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX SODASORB CO2 ABSORBENT; ABSORBER, CARBON-DIOXIDE PRODUCT CODE: BSF

Catalog Number 008870

Device Problem Failure to Cycle (1142)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Information was received that a smiths medical portex sodasorb co2 absorbent was broken, which generated an "error" alarm on the machine.Event occured prior to use with a patient.No adverse effects were reported.

• Brand Name: PORTEX SODASORB CO2 ABSORBENT
• Type of Device: ABSORBER, CARBON-DIOXIDE PRODUCT CODE: BSF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD; boundary road; hythe, kent ; UK
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 8499876
• MDR Text Key: 141751228
• Report Number: 3012307300-2019-01905
• Device Sequence Number: 1
• Product Code: BSF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 008870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Date Manufacturer Received: 03/13/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1