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

Model Number MEDISORB EX, PKG OF 6 PCS

Device Problem Output Problem (3005)

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

Event Date 05/10/2023

Event Type  malfunction  

Event Description

It was reported to vyaire medical that the etco2 (end-tidal carbon dioxide) level on 2079796-001 - medisorb ex, pkg of 6 pcs, showed higher than normal during usage.The customer also mentioned that they are unable to identify how long it was used.The customer confirmed that there was no patient harm or injury 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

Device evaluation: g3, g6, h2, h3, h6 and h10 production records showed no deviations from the specification of the device during manufacture.All units packed passed a 100% leak test and visual inspection.A review of the batch documentation under lot l01a-01340 found no issues that could be linked to damage.The returned sample has been visually inspected, and damage found at the canister¿s bottom has been identified, which would indicate that the most likely cause is that the canister was subjected to a significant force during transportation after the 100% in-line leak and visual inspection check in the manufacturing line.The device returned was in very poor condition, severely damaged, and damp, causing the material contained in it to fail all performance tests.Material retention samples were tested for caco3, usp co2 absorption, and moisture absorption, and both passed the tests within spec.The caco3 result shows that although the soda lime has been used, there is still capacity for the device to absorb co2 (exhaustion results typically range from 60 to 80%).Due to the device being decontaminated with solution (externally and internally), this affected the moisture and the performance of the soda lime, and mpl cannot ascertain if the material from this device was ok before being decontaminated.Retain samples have been tested and show that the material is still performing as intended if used and stored correctly.

• Brand Name: MEDISORB¿ EX, DISPOSABLE
• Type of Device: ABSORBENT, CARBON-DIOXIDE
• Manufacturer (Section D): VYAIRE MEDICAL OY; kuortaneenkatu 2; etela-suomen laani; helsinki ; FI
• Manufacturer (Section G): MOLECULAR PRODUCTS LTD; parkway harlow business park; harlow, essex CM19 5FR; UK CM19 5FR
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 17080139
• MDR Text Key: 317645288
• Report Number: 3010838917-2023-00061
• 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: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/07/2023

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: Health Professional
• Device Model Number: MEDISORB EX, PKG OF 6 PCS
• Device Catalogue Number: 2079796-001
• Device Lot Number: L01A-01340
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/10/2023
• Initial Date FDA Received: 06/07/2023
• Supplement Dates Manufacturer Received: 09/06/2023
• Supplement Dates FDA Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1