MAUDE Adverse Event Report: COOK MEDICAL WAYNE PNEUMOTHORAX TRAY

Lot Number 5020866

Device Problem Positioning Problem (3009)

Patient Problems Pneumothorax (2012); Swelling (2091)

Event Type  Injury  

Event Description

A (b)(6) male pt with a radiographically confirmed pneumothorax underwent percutaneous placement of a 14 french pigtail catheter (wayne pneumothorax tray, cook medical, (b)(4)), which includes a one way heimlich valve.A chest x-ray performed immediately after the procedure demonstrated appropriate positioning of the pleural catheter, but interval enlargement of the pneumothorax and development of radiographic features of tension pneumothorax.The pt's clinical condition remained stable.Examination of the chest tube assembly revealed reversal of the intended orientation of the heimlich valve.The valve was reinstalled in the correct location, and a repeat x-ray revealed resolution of the pneumothorax and all radiographic features of tension pneumothorax.The pt was admitted for further management.The heimlich valve is often used with thoracostomy tubes and other medical devices requiring unidirectional flow.The heimlich valve is a simple mechanical valve, consisting of a flexible and collapsible tube inside a cylindrical chamber.Positive pressure through one end of the valve creates flow through the flexible tube.Negative pressure collapses the tube, preventing flow reversal.The result is a one way valve.The pt's normal respirations create the positive and negative pressure cycle, pumping air or fluid out of the pleural space when the valve is properly positioned.Advantages of the valve include a simple design that does not require the application of a powered suction device and low cost.Pt's with pneumothoraces and thoracostomy tubes can be transported or can be ambulatory while disconnected from wall suction with a heimlich valve attached to the thoracostomy tube.In some cases, pts are even discharged from the hospital with thoracostomy tubes and heimlich valves in place.The design of a heimlich valve mandates unidirectional flow, the direction of which is determined by the orientation of the valve.Reversal of the valve reverses the direction of flow.In the case of a thoracostomy tube equipped with a heimlich valve, reversal of the valve results in the entrainment of atmospheric air through the tube into the pleural space when the pt inspires.That air is then trapped within the pleural space and cannot escape through the heimlich valve.Within a short period of time, the accumulation of air in the pleural space can lead to an enlarging pneumothorax as in the pt described.Failure of healthcare providers to recognize the error and correct the valve orientation could result in clinical tension pneumothorax and death.Reversal of the intended valve orientation is possible at the time of initial insertion, during tube manipulation by medical staff (nurses, physicians, or other), or even by pts, some of whom may not be under medical supervision.The heimlich valve included in the wayne pneumothorax tray (cook medical, (b)(4)) is symmetrically designed, with conical "christmas tree" adaptors at each end.Consequently, the valve can be inserted in the incorrect orientation into the included thoracostomy tube adaptor, which terminates in a funnel shaped opening.The device could be redesigned with asymmetrical connections, preventing incorrect insertion.Labels on the device correctly indicate the direction of flow but are ambiguous and difficult to read.The valve itself bears no warning of the potentially dire consequences of improper orientation.An explicit warning label could be added to the valve within the kit to draw attention to the correct orientation and risks.The manufacturer instructions for valve insertion are ambiguous and brief and could be improved with figures and explicit warnings.Instructions for pts and first-responders about the risks of the valve are also needed, particularly given that the valve may be used in an outpatient setting.

• Brand Name: WAYNE PNEUMOTHORAX TRAY
• Type of Device: WAYNE PNEUMOTHORAX TRAY
• Manufacturer (Section D): COOK MEDICAL; bloomington IN
• MDR Report Key: 4475853
• MDR Text Key: 5325340
• Report Number: MW5040515
• Device Sequence Number: 1
• Product Code: DQR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 5020866
• Other Device ID Number: (01)00827002120327 (17)160500(
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/27/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR