MAUDE Adverse Event Report: VYAIRE MEDICAL OY MEDISORB EX, PKG OF 6 PCS; CO2 ABSORBERS

Model Number MEDISORB EX, PKG OF 6 PCS

Device Problems Crack (1135); Leak/Splash (1354)

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

Event Date 07/20/2022

Event Type  Injury  

Event Description

It was reported to vyaire medical that the cracked on medisorb product leaked into an anaesthetic circuit while connected to a patient.The customer stated that the medisorb was switched out for a new one during the procedure.The customer confirmed that there was no patient harm associated with the reported event.

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.

• Brand Name: MEDISORB EX, PKG OF 6 PCS
• Type of Device: CO2 ABSORBERS
• Manufacturer (Section D): VYAIRE MEDICAL OY; kuortaneenkatu 2; helsinki etela-suomen laani; helsinki, 510 ; FI 510
• Manufacturer (Section G): MOLECULAR PRODUCTS LTD; parkway harlow; business park harlow; harlow, essex, CM19 5FR; UK CM19 5FR
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 15256081
• MDR Text Key: 298199280
• Report Number: 3010838917-2022-00008
• Device Sequence Number: 1
• Product Code: CBL
• Combination Product (y/n): Y
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MEDISORB EX, PKG OF 6 PCS
• Device Catalogue Number: 2079796-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2022
• 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