MAUDE Adverse Event Report:; ANESTHESIA CIRCUIT

Catalog Number DYNJAAF6735

Device Problem Loss of or Failure to Bond (1068)

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

Event Date 02/09/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that the circuit became unbonded on a patient.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.There was no medical intervention or serious injury reported related to this event.No sample was returned for evaluation.Due to the reported incident and in an abundance of caution, this is a reportable event.If additional relevant information becomes available this report will be reopened and reevaluated.

Event Description

It was reported that the circuit became unbonded on a patient.

Manufacturer Narrative

Follow up information obtained from the facility on 3/11/2021.It was reported that during an aortic valve replacement the circuit was in use for approximately five hours when the spo2 was noted to be dropping toward the end of the patient's surgical procedure just prior to the patient being transport out of the surgical suite.The staff noted the expiratory tube was disconnected.There was no medical intervention or follow up required related to the reported incident.There was no impact to the patient or the procedure that was being performed.The facility reported that the patient is now deceased, however the cause was not related to the reported event.Corrected information: d9-sample returned (b)(6) 2021.A sample was returned for evaluation.The lot number reported was 20jbk889.It was stated the circuit was becoming unbonded.The sample showed the plastic on the blue inner tubing was not bonded on the machine connector.

• Type of Device: ANESTHESIA CIRCUIT
• MDR Report Key: 11457403
• MDR Text Key: 256450201
• Report Number: 1417592-2021-00037
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: DYNJAAF6735
• Device Lot Number: 20JBK889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2021
• Date Manufacturer Received: 03/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 146