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

Model Number MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE

Device Problem Device Alarm System (1012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the product sample and photo is available for analysis.At this time, vyaire has not received the suspect device for evaluation.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 a color indicator issue with medisorb multi-absorber original, disposable, the soda lime appears white while the inspiration indicates 0.5-0.9 kpa co2, after replacement, the customer notice a discreet purple coloration.The event occurred while connected to a patient.The customer confirmed that no patient harm was associated on this event.

Manufacturer Narrative

The technical support was unable to determine the root cause of the reported issue.The manufacturers record was reviewed and all units are leak tested after manufacture and prior to packing with any product found leaking will automatically rejected from the line and discarded accordingly.As a result of trend / repeat occurrences analysis a capa has been raised within mpl for the issue of damage to medisorb multi absorber and ex canisters.Investigation and any actions identified will be progressed through the capa.

• Brand Name: MEDISORB MULTI-ABSORBER ORIGINAL, DISPOSABLE
• Type of Device: ABSORBENT, CARBON-DIOXIDE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 9926111
• MDR Text Key: 202554795
• Report Number: 3002807637-2020-00003
• Device Sequence Number: 1
• Product Code: CBL
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2020
• 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?: Yes
• Date Manufacturer Received: 05/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1