MAUDE Adverse Event Report: MEDLINE ANESTHESIA CIRCUIT LF

Model Number LF

Device Problems Cut In Material (2454); Connection Problem (2900)

Patient Problem Dyspnea (1816)

Event Date 01/25/2016

Event Type  Injury  

Event Description

After flipping pt for prone surgical case, anesthesia noted the pt to have high airway pressures and sats in range of 92%.After some trouble shooting by anesthesia, there was found to be no kinks in et tube and sats were stabilized at or above 98%.The surgery was performed without incident.At procedure end the pt was placed back in supine position, airway pressures were noted to be high, but pt sats were good.After disconnecting circuit, pt was able to breathe more easily, anesthesia tried to bag air through circuit while it was not connected to pt and again it seemed that there was some type of obstruction in the circuit tubing which did allow pressurized air flow.At this time surgery is over and pt is breathing on his own.Upon further investigation, there appeared to be some type of plastic mid way down circuit that was visible while looking down the tube.Nurse manager was notified, tubing was cut and there was found to be some type of clear plastic wrap that was lodged in the circuit tubing.Diagnosis or reason for use: anesthesia circuit - used to ventilate pt.Event abated after use stopped or dose reduced: yes.

• Brand Name: ANESTHESIA CIRCUIT LF
• Type of Device: ANESTHESIA CIRCUIT
• Manufacturer (Section D): MEDLINE
• MDR Report Key: 5445261
• MDR Text Key: 38632476
• Report Number: MW5060272
• Device Sequence Number: 1
• Product Code: CAI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LF
• Device Lot Number: 15KB627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2016
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 55 YR
• Patient Weight: 83