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

Model Number MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE

Device Problem Break (1069)

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

Event Date 05/05/2021

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

The customer reported that the medisorb¿ multi-absorber original, disposable experienced broken cartridges.The issue occurred during patient-use and the customer confirmed that there was no patient harm associated with the reported event.

Manufacturer Narrative

Result of investigation: sample received for evaluation.Sample was leak tested and although it was found to be leaking at 10.9ml/min over 100 cmh2o, this was within vyaire's specification of < 20ml/min in accordance with pqas-8003138 et al-ca.Therefore no root cause could be determined.All units packed passed 100% leak test and visual inspection.A review of the batch documentation for lot l01a-00256 found no issues that could be linked with damage failures on this batch.The 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.Capa 21-013 has been opened up due to leak failures and these type of complaints are being tracked on our complaints system.

• Brand Name: MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE
• Type of Device: ABSORBENT, CARBON DIOXIDE
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): MOLECULAR PRODUCTS LTD; parkway harlow business park; harlow, essex, CM19 5FR; UK CM19 5FR
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618
• MDR Report Key: 12081301
• MDR Text Key: 263511896
• Report Number: 3002807637-2021-00019
• Device Sequence Number: 1
• Product Code: CBL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/02/2021

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
• Device Operator: Health Professional
• Device Model Number: MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE
• Device Catalogue Number: 8003138
• Device Lot Number: L01-00256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2021
• Initial Date FDA Received: 06/28/2021
• Supplement Dates Manufacturer Received: 11/21/2021
• Supplement Dates FDA Received: 12/14/2021
• 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