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

Model Number	MULTI ABSORBER EF, DISPOSABLE
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: 81 other - at this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.On follow-up, the customer confirmed that the affected product caused the patient to inhale breaths from which c02 hadn't been removed.Also, fic02 was elevated to 9.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 returned yet.
Event or Problem Description
It was reported to vyaire medical that the m1173311 - multi absorber ef, disposable was not absorbing any co2.The reported issue happened during patient use; unknown patient impact.
Additional 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 number l01a-01526 was within specifications on usp co2 absorption.The returned samples were received in such poor condition; the packaging did not state they were fragile units, and all canisters had cracks due to damage during transportation until our facilities, exposing the soda lime to the elements, making them unsuitable to be subjected to tests and reflecting accurate results.We conducted a thorough evaluation of retained samples (devices and material) from the same batch retained by the manufacturer.These units were subjected to visual inspections, leak tests, and usp co2 absorption assessments, and all retained samples successfully met the required standards.Possible causes of the lack of absorption could be issues linked to: a) the flow rate of gas through the absorber may be too high or too low, affecting the absorption efficiency; b) the equipment used to measure co2 levels may require calibration or maintenance; or c) human error, such as incorrect settings or adjustments during use.

• Brand Name: MEDISORB¿ EF MULTI-ABSORBER, DISPOSABLE
• Common Device Name: 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: 17506911
• Report Number: 3010838917-2023-00070
• Device Sequence Number: 17766280
• Product Code: CBL
• UDI-Device Identifier: 10190752184336
• UDI-Public: (01)10190752184336(10)L01A-01526
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2023

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
• Operator of Device: Health Professional
• Device Model Number: MULTI ABSORBER EF, DISPOSABLE
• Device Catalogue Number: M1173311
• Device Lot Number: L01A-01526
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2023
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown