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

Model Number MEDISORB, MULTI ABSORBER ORIGINAL

Device Problem Leak/Splash (1354)

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

Event Date 03/14/2023

Event Type  malfunction  

Manufacturer Narrative

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.H3 other text : device not yet returned.

Event Description

It was reported to vyaire medical that the bellows do not stay inflated after changing the medisorb, multi absorber original during procedure.The leak rate is greater than 750ml.The soda lime container was replaced which resolved the issue.The patient was not harmed.

• 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: 17088741
• MDR Text Key: 316986631
• Report Number: 3010838917-2023-00062
• Device Sequence Number: 1
• Product Code: CBL
• UDI-Device Identifier: 10190752184329
• UDI-Public: (01)10190752184329
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MEDISORB, MULTI ABSORBER ORIGINAL
• Device Catalogue Number: M1173310
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/12/2023
• Initial Date FDA Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: No
• 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