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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL MEDISORB LOOSE FILL TWINPACK 4.5 KG (9.9 LB.), DISPOSABLE; ABSORBENT, CARBON-DIOXIDE
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VYAIRE MEDICAL MEDISORB LOOSE FILL TWINPACK 4.5 KG (9.9 LB.), DISPOSABLE; ABSORBENT, CARBON-DIOXIDE Back to Search Results
Model Number MEDISORB¿ LOOSE FILL TWINPACK 4.5 KG (9.9 LB.), DISPOSABLE, CARBON DIOXIDE ABSOR
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/01/2020
Event Type  malfunction  
Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.Therefore, no root cause could be determined yet.
 
Event Description
It was reported to vyaire medical that the new soda lime canister was exhausted while connected to an animal patient at a veterinary practice.There was no harm associated with the event as the defective medisorb was replaced with the backup unit.
 
Manufacturer Narrative
Device evaluation: d9, g3, g6, h2, h3, h6 and h10 h10: vyaire medical received the device and performed an evaluation.However, the reported issue was not reproducible.Vyaire medical ensured all components are up to date and continued per service processing procedure.The suspect device/component passed all testing and met all specifications.
 
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Brand Name
MEDISORB LOOSE FILL TWINPACK 4.5 KG (9.9 LB.), DISPOSABLE
Type of Device
ABSORBENT, CARBON-DIOXIDE
Manufacturer (Section D)
VYAIRE MEDICAL
26125 n. riverwoods blvd.
mettawa IL 60045
MDR Report Key10909216
MDR Text Key242077257
Report Number3002807637-2020-00009
Device Sequence Number1
Product Code CBL
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 11/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/13/2024
Device Model NumberMEDISORB¿ LOOSE FILL TWINPACK 4.5 KG (9.9 LB.), DISPOSABLE, CARBON DIOXIDE ABSOR
Device Catalogue Number8570043
Device Lot Number8710319
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2021
Date Manufacturer Received05/10/2021
Is This a Reprocessed and Reused Single-Use Device? Yes
Patient Sequence Number1
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