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

Model Number MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE

Device Problem Product Quality Problem (1506)

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

Event Date 04/19/2022

Event Type  Injury  

Event Description

The customer reported that end user immediately noticed unusual co2 trace pattern/waveform on the anesthesia machine during hip replacement operation.The patient was transferred to a different machine in good time, and no harm is associated with the incident.However, it did cause stress to the team.Upon checking, the medisorb¿ multi-absorber original, disposable cannisters seemed to be too full or unable to shake or did not seem to have the movement as they normally do.This was proven by using a different product (unspecified).Also, general electric was called to test their equipment, and this passed and was in good working order.

Manufacturer Narrative

(b)(4).At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE
• Type of Device: ABSORBENT, CARBON-DIOXIDE
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 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, IL 92618 ; 7149227837
• MDR Report Key: 14441280
• MDR Text Key: 294761867
• Report Number: 3002807637-2022-00030
• 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: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2022
• 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: LOIA-00962,00648,0520120,00088
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2022
• 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
• Patient Age: 66 YR
• Patient Weight: 80 KG