MAUDE Adverse Event Report: ICU MEDICAL, INC. TRANSPAC IV; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Device Problem Gas/Air Leak (2946)

Patient Problem Air Embolism (1697)

Event Date 02/08/2017

Event Type  malfunction  

Event Description

Ecmo circuit manifold had white air vent cap at the end that rn mistakenly turned the stopcock open to allow air to into the circuit and into the patient (air emboli).Ecmo manifold had lasix and heparin infusing into it.Lasix was infusing via syringe pump and heparin via alaris infusion pump.Air entered heparin drip that was infusing into ecmo circuit.Rn turned heparin drip stopcock to the off position on ecmo circuit manifold in order to remove the air from alaris pump heparin tubing.When doing this air entered the ecmo circuit.It was then noted that a white air vent cap had been placed previously onto the end of the manifold (usually it is a red dead end cap).(air entering the drip tubing while on ecmo with the carefusion alaris pumps is an ongoing issue with all our ecmo drips).Bubble alarm warning went off and immediately the arterial cannula was grabbed to stop forward flow; then our process of clamping the ecmo circuit was initiated.Unfortunately at the time we saw air in the arterial cannula.This air was removed by using the double clamp method, we assumed that air had entered the arterial cannula.

• Brand Name: TRANSPAC IV
• Type of Device: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city UT 84123
• MDR Report Key: 9805266
• MDR Text Key: 182556654
• Report Number: 9805266
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/07/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 365 DA