MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; ANESTHESIA CIRCUIT PEDS UNI-LF

Catalog Number DYNJAPF6057A

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that during the start of the anesthetic, while the patient was undergoing an esophagogastroduodenoscopy (egd) and a colonoscopy procedure, the inspiration and exploratory channels were not able to communicate due to the green inspiration limb becoming unbonded at one end resulting in patient rebreathing which caused a transient increase in co2 levels.The patient was ventilated with an ambu bag and switched to a new circuit without further incident.The customer reported that there was a one hour delay in the procedure to resolve the issue; however the procedure was able to be completed without further impact or follow up treatment required.General anesthesia was used and the patient was under anesthesia longer than expected.There was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident or the additional anesthesia.The sample was returned to the manufacturer for evaluation and the root cause was determined to be due to an improperly bonded circuit.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

It was reported that the anesthesia circuit was not bonded leading to inaccurate co2 levels during a procedure.

• Type of Device: ANESTHESIA CIRCUIT PEDS UNI-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093 ; 8476434960
• MDR Report Key: 9174788
• MDR Text Key: 170108087
• Report Number: 1417592-2019-00174
• Device Sequence Number: 1
• Product Code: CAI
• UDI-Device Identifier: 10889942976577
• UDI-Public: 10889942976577
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJAPF6057A
• Device Lot Number: 19GB1659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Date Manufacturer Received: 09/27/2019
• 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
• Patient Age: 12 YR
• Patient Weight: 40