MAUDE Adverse Event Report: VYAIRE MEDICAL OY MEDISORB EX, PKG OF 6 PCS; ABSORBENT, CARBON-DIOXIDE

Model Number MEDISORB EX, PKG OF 6 PCS

Device Problem Defective Device (2588)

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

Event Date 01/04/2023

Event Type  malfunction  

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The customer reported to vyaire medical that the medisorb¿ ex, disposable canister cannot absorb carbon dioxide.The said issue occurred during surgery and the customer confirm no harm was done to the patient.

Manufacturer Narrative

Device evaluation: g3, g6, h2, h3, h6 and h10.Result of investigation: the suspect device was returned for product evaluation.All units packed passed 100% leak test and visual inspection.Review of the batch documentation under lot l01a-01173 found no issues that could be linked with damage failures on these batches.The calcium carbonate content was well within specification of unused material (<4.1%) and should have been able to perform as intended.After the device was tested, it was found on the decontamination form that the device lid was broken which may have caused leakage in the system and why it could not perform as intended.Pallet and carton for canisters clearly states that they are fragile and to handle with care.Devices are packaged in a carton that meets the vyaire drop testing specification.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: MEDISORB EX, PKG OF 6 PCS
• Type of Device: ABSORBENT, CARBON-DIOXIDE
• Manufacturer (Section D): VYAIRE MEDICAL OY; kuortaneenkatu 2 helsinki ete; la-suomen laani, finland fin; helsinki 00510 ; FI 00510
• 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
• MDR Report Key: 16236249
• MDR Text Key: 308921671
• Report Number: 3010838917-2023-00040
• 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: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2023
• 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-01173
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/28/2023
• 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: Unknown
• Patient Sequence Number: 1