MAUDE Adverse Event Report: KING SYSTEMS JACKSON REES BREATHING CIRCUIT; NON-REBREATHING CIRCUIT

Model Number 61743Z

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Cardiac Tamponade (2226)

Event Date 02/22/2016

Event Type  malfunction  

Manufacturer Narrative

The attached device evaluation confirmed no device defect found.

Event Description

As received from the complainant: "near-cardiac arrest (pulseless electrical activity) due to faulty valve in a disposable jackson-rees breathing circuit, leading to thoracic tamponade physiology: the patient was moved from or table to stretcher after aortic valve and hemi-aortic root replacement surgery.A king systems disposable jackson-rees circuit (ref 61743z) with 8 l/m oxygen flow was attached to the patient's endotracheal tube (ett).The patient was breathing spontaneously.The pop-off valve was adjusted to be partially open (the slide switch was not fully to the left).Within approximately 1 min, the patient had a brief but progressive episode of bradycardia, hypotension, and ultimately pulseless electrical activity.The reservoir bag was not visible to the anesthesiologist (tucked to the left of the patient's head).As the team prepared to transfer the patient back to the or table urgently, the j-r circuit spontaneously disconnected from the ett.The anesthesiologist found that its pop-off valve was fully closed (judged by looking directly at the hemicircular vent orifice), even though the slider controlling the valve was not in the fully closed position.After manipulating the slider to open the valve fully as confirmed visually by inspecting the orifice, the circuit was reattached to the ett.Bilateral and equal breath sounds were auscultated.The patient's hemodynamics promptly recovered.The patient did not manifest any lung injury, likely due to the high-volume/low-pressure reservoir coupled with the fortuitous disconnection of the circuit from the ett.".

• Brand Name: JACKSON REES BREATHING CIRCUIT
• Type of Device: NON-REBREATHING CIRCUIT
• Manufacturer (Section D): KING SYSTEMS; 15011 herrinman blvd.; noblesville IN 46060
• Manufacturer (Section G): KING SYSTEMS; 15011 herriman blvd.; noblesville IN 46060
• Manufacturer Contact: wayne nethercutt ; 15011 herriman blvd.; noblesville, IN 46060 ; 3177763175
• MDR Report Key: 5511093
• MDR Text Key: 40728105
• Report Number: 1824226-2016-00001
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 61743Z
• Device Catalogue Number: 61743Z
• Device Lot Number: 1838807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention