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

Model Number MEDISORB¿ EF MULTI-ABSORBER, DISPOSABLE

Device Problem Leak/Splash (1354)

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

Event Date 04/28/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturer of the anesthesia machine indicated that the leak rate was 2.4 l/min.Troubleshooting was carried out and revealed all three handwheel screws of the circuit system were loose.They were tightened, and function test passed, and the system is fully functional and handed over to the customer for patient operation.The operational verification procedure was performed and passed.Having met manufacture specifications the device was returned for use.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 large leakage in the system while anesthesia machine was running.It was using a medisorb¿ ef multi-absorber, disposable canister.Because of the leakage, no minimal flow anesthesia could be performed.The end user replaced the machine.No consequence to the patient.

• Brand Name: MEDISORB EF MULTI-ABSORBER, 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: erika bonilla ; 510 technology dr,; irvine, CA 92618 ; 7149227837
• MDR Report Key: 11881926
• MDR Text Key: 257161565
• Report Number: 3002807637-2021-00013
• Device Sequence Number: 1
• Product Code: CBL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MEDISORB¿ EF MULTI-ABSORBER, DISPOSABLE
• Device Catalogue Number: M1173311
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/28/2021
• Initial Date FDA Received: 05/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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