MAUDE Adverse Event Report: VYAIRE MEDICAL MEDISORB EX, DISPOSABLE; ABSORBENT, CARBON-DIOXIDE

Model Number MEDISORB¿ EX, DISPOSABLE

Device Problem Leak/Splash (1354)

Patient Problem Low Oxygen Saturation (2477)

Event Date 03/22/2021

Event Type  Injury  

Manufacturer Narrative

According to the customer, suspect sample/s and photos are not available.The soda lime canister was disposed of by the staff on site and no means of retrieving it.Therefore, no root cause can be determined.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¿ ex, disposable experienced leak due to crack in absorbent canister.The issue occurred during patient-use.Saturation dropped to 89% only for a matter seconds and returned to normal levels quickly.As an intervention, they used aux o2 (auxiliary oxygen) port on machine to give oxygen,used bag valve mask (bvm) and replaced the cracked canister.

• Brand Name: MEDISORB EX, DISPOSABLE
• Type of Device: ABSORBENT, CARBON-DIOXIDE
• Manufacturer (Section D): VYAIRE MEDICAL; 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: peter sparacio ; 26125 n. riverwoods blvd.; mettawa, IL 60045 ; 8333273284
• MDR Report Key: 11788067
• MDR Text Key: 249709199
• Report Number: 3002807637-2021-00012
• Device Sequence Number: 1
• Product Code: CBL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MEDISORB¿ EX, DISPOSABLE
• Device Catalogue Number: 2079796-001
• Device Lot Number: (10)L01A-00093
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention