MAUDE Adverse Event Report: VYAIRE MEDICAL MEDISORB EX, DISPOSABLE; ABSORBENT, CARBON-DIOXIDE

Model Number MEDISORB¿ EX, DISPOSABLE

Device Problem Crack (1135)

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

Event Date 11/08/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported the product sample and photo is available for analysis.At this time, vyaire has not received the suspect device for evaluation.Any additional information provided by the customer will be included in a follow-up report.

Event Description

The customer reported that the medisorb ex sodalime canister was cracked at the bottom which lead to leakage in the aneshesia machine.The event occurred while connected to a patient during the surgical procedure.The customer reported that they had replaced the canister to prevent patient harm; and confirmed that no patient harm was associated on this event.

Manufacturer Narrative

Photo analysis confirmed the reported failure.However, it was determined that it was mostly likely caused by a significant force applied to the canister after the 100% leak check in the manufacturing line (post shipment).In addition, review of the device history record as well as batch documentation reveals no issues.Root cause of failure was determined to be shipping damage, outside of manufacturer's control.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: MEDISORB EX, DISPOSABLE
• Type of Device: ABSORBENT, CARBON-DIOXIDE
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 9402130
• MDR Text Key: 190006792
• Report Number: 3002807637-2019-00002
• Device Sequence Number: 1
• Product Code: CBL
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MEDISORB¿ EX, DISPOSABLE
• Device Catalogue Number: 2079796-001
• Device Lot Number: 4020719
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1