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

Model Number MEDISORB, MULTI ABSORBER CANISTER

Device Problem Leak/Splash (1354)

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

Event Date 04/11/2023

Event Type  malfunction  

Manufacturer Narrative

Vyaire medical file identification:(b)(4) h3: 81 other - 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

It was reported to vyaire medical that the 8003138 medisorb, multi absorber canister was found leaking.At this time, there is no information regarding patient involvement associated with the reported event.

Manufacturer Narrative

H10.Additional mfr narrative/corrected device evaluation update: g3, g6, h2, h3, h6 and h10 results of investigation: vyaire medical was able to verify the reported issue.The production records revealed no deviations from the device's specifications throughout manufacture.All packed products passed a 100% leak test and visual inspection.A review of the batch documentation for lot l01a-01381 revealed no problems that could be attributed to damage.The returned sample was visually inspected, and leak tested; multiple cracks were discovered at the canister's top, indicating that the canister was subjected to significant force during transportation following the 100% in line leak and visual inspection check in the manufacturing line.Vyaire has investigated broken canisters reported by customers and vyaire has implemented adjustment to the packaging and these modifications are currently ongoing.

• Brand Name: MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE
• Type of Device: ABSORBENT, CARBON-DIOXIDE
• Manufacturer (Section D): VYAIRE MEDICAL OY; kuortaneenkatu 2 helsinki ete; la-suomen laani,; helsinki ; FI
• Manufacturer (Section G): MOLECULAR PRODUCTS INC; parkway, harlow business park; harlow,essex CM19 5FR; UK CM19 5FR
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618
• MDR Report Key: 17128284
• MDR Text Key: 317872918
• Report Number: 3010838917-2023-00063
• Device Sequence Number: 1
• Product Code: CBL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MEDISORB, MULTI ABSORBER CANISTER
• Device Catalogue Number: 8003138
• Device Lot Number: L01A-01335
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2023
• 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