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

Model Number MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE

Device Problem Leak/Splash (1354)

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

Event Date 07/01/2021

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 leak in the system while connected to anaesthesia machine due to small cracks observed in canisters.Additional medisorb canisters had to be located.The customer confirmed that there was no patient harm associated with the reported event.

Manufacturer Narrative

Result of investigation: a sample was returned of lot 5120720 which had catastrophic damage to one of the feet of the device allowing material to fall out leaving investigator unable to perform a leak test and ascertain where the original leak was coming from.It is unknown whether this happened on route to customer or on route back to investigator.Unable to determine failure due to a damaged return sample.

• 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: 12289035
• MDR Text Key: 265429702
• Report Number: 3002807637-2021-00022
• Device Sequence Number: 1
• Product Code: CBL
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 07/12/2021

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2021
• Initial Date FDA Received: 08/06/2021
• 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