MAUDE Adverse Event Report: VYAIRE MEDICAL 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 09/15/2021

Event Type  Injury  

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

It was reported to vyaire medical that the 8003138-medisorb¿ multi-absorber original, disposable did not pass the checks for automatic ventilation nor for manual ventilation.The soda lime canister was removed for inspection, and it was found that there was no damage to the canister.The soda lime canister was repositioned and the user test was passed again.The medisorb has now successfully passed the automatic and manual user tests.Once put into normal operation for a fixed vt of 500 ml (vcv mode), the equipment shows a vt of 488 ml.Intensive tests were carried out to ensure the proper functioning of the equipment.During the incident, the user began to ventilate in manual mode and then de-intubated the patient.The endoscopic procedure was discontinued but there was no patient harm.

• Brand Name: MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE
• Type of Device: ABSORBENT, CARBON DIOXIDE
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine CA 92618
• 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, CA 92618
• MDR Report Key: 14762402
• MDR Text Key: 294924610
• Report Number: 3002807637-2022-00032
• Device Sequence Number: 1
• Product Code: CBL
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE
• Device Catalogue Number: 8003138
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/09/2022
• 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