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

Model Number MEDISORB, MULTI ABSORBER CANISTER

Device Problems Crack (1135); Leak/Splash (1354)

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

Event Date 08/08/2022

Event Type  malfunction  

Manufacturer Narrative

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

The customer reported to vyaire medical that the medisorb, multi absorber canister has a broken soda lime canister which causes leak during patient use.The customer confirmed that there was no patient harm associated with the reported event.

Manufacturer Narrative

Result of investigation - the suspect device was not returned.Device history record review shows no deviation to specification of device during manufacture.It was determined that shipping or transport may be related with the reported defect since pallet and carton for canisters cearly states that they are fragile and to handle with care.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: MEDISORB, MULTI ABSORBER CANISTER
• 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 ; 7149227837
• MDR Report Key: 15411993
• MDR Text Key: 306188670
• Report Number: 3010838917-2022-00012
• Device Sequence Number: 1
• Product Code: CBL
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/17/2022

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 CANISTER
• Device Catalogue Number: 8003138
• Device Lot Number: L01A-00927
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/17/2022
• Initial Date FDA Received: 09/13/2022
• Supplement Dates Manufacturer Received: 02/13/2023
• Supplement Dates FDA Received: 04/18/2023
• 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: Unknown
• Patient Sequence Number: 1