MAUDE Adverse Event Report: VYAIRE MEDICAL MEDISORB MULTI-ABSORBER ORIGINAL, DISPOSABLE; ABSORBENT, CARBON-DIOXIDE

Model Number MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/25/2020

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¿ multiabsorber canister has a gap at the bottom which lead to leakage.The event occurred while connected to a patient however the customer confirmed that no patient harm was associated on this event.

Manufacturer Narrative

Device evaluation: g4, g7, h2, h3, h6 and h10.Result of investigation: photo provided confirmed the reported failure.However, investigation revealed that all units undergo leak testing after manufacture and before packaging.Any product found to be leaking is automatically rejected and discarded.Also, device history review revealed no issues, and all units passed testing.As such, the crack leading to leakage is most likely due to the canister being subjected to a significant force after the 100% in line leak check.

• Brand Name: MEDISORB MULTI-ABSORBER ORIGINAL, DISPOSABLE
• Type of Device: ABSORBENT, CARBON-DIOXIDE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 10026193
• MDR Text Key: 209216698
• Report Number: 3002807637-2020-00005
• 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: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE
• Device Catalogue Number: 8003138
• Device Lot Number: 8881119
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1