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

Model Number MEDISORB EX, PKG OF 6 PCS

Device Problem Leak/Splash (1354)

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

Event Date 05/24/2023

Event Type  malfunction  

Event Description

It was reported to vyaire medical that when a leak test was performed on 2079796-001 - medisorb ex, pkg of 6 pcs, prior to use on a patient, it passed.However, when the anesthetic machine was started, it showed signs of leakage.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

Production records showed no deviations from the specifications 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.Vyaire medical received the sample in bad condition.The canister was filled with water and leaking.The box that contained the sample was not damaged.After visual inspection, a big crack at the canister¿s bottom was 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.

• 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: 17152800
• MDR Text Key: 317843680
• Report Number: 3010838917-2023-00066
• 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: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2023
• 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
• Date Manufacturer Received: 08/28/2023
• 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