MAUDE Adverse Event Report: VYAIRE OY MEDISORB EX; MEDISORB EX, PKG OF 6 PCS

Model Number 2079796-001

Device Problems Defective Component (2292); Defective Device (2588); Material Integrity Problem (2978)

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

Event Date 08/30/2023

Event Type  Injury  

Event Description

It was reported to vyaire medical that the 79796-001 medisorb ex, pkg of 6 pcs wasn't absorbing co2 while connected to the patient.The defective canister was immediately removed and was replaced with a new one.The customer confirmed that there was no patient harm associated with the reported event.

Manufacturer Narrative

H3: 81 other - at this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Manufacturer Narrative

H3: 81 other - at this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.Failure was confirmed, due to a leak from damaged lid.Root cause couldn't be determined.Reviewed sha - rmf-hl-0053 - co2 absorption products and components - mdd - rev07 - 12-dec-2023.Closest risk sha-hl-0053-035 excessive carbon dioxide or carbon dioxide build up during ventilation (insufficient carbon dioxide removal) possible causes being co2 is not absorbed because: reuse of soda lime, too long use, defect on use, defect on absorber, supplier investigation suggests defect on absorber.

Event Description

It was reported to vyaire medical that the 79796-001 medisorb ex, pkg of 6 pcs wasn't absorbing co2 while connected to the patient.The defective canister was immediately removed and was replaced with a new one.The customer confirmed that there was no patient harm associated with the reported event.

• Brand Name: MEDISORB EX
• Type of Device: MEDISORB EX, PKG OF 6 PCS
• Manufacturer (Section D): VYAIRE OY; kuortaneenkatu 2; etela-suomen laani; helsinki uusimaa, fl FIN-0 0510; FI FIN-00510
• Manufacturer (Section G): MOLECULAR PRODUCTS LTD; parkway harlow; business park harlow; harlow, essex CM195 FR; UK CM195FR
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 17807840
• MDR Text Key: 324140410
• Report Number: 3010838917-2023-00081
• Device Sequence Number: 1
• Product Code: CBL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2079796-001
• Device Catalogue Number: 2079796-001
• Device Lot Number: L0LA-01510
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention