TRANSPAC IV

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-09 for TRANSPAC IV manufactured by Icu Medical, Inc..

Event Text Entries

[182556654] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9805266
• MDR Report Key: 9805266
• Date Received: 2020-03-09
• Date of Report: 2020-01-07
• Date of Event: 2017-02-08
• Report Date: 2020-01-07
• Date Reported to FDA: 2020-01-07
• Date Reported to Mfgr: 2020-03-09
• Date Added to Maude: 2020-03-09
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: TRANSPAC IV
• Generic Name: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Product Code: DRS
• Date Received: 2020-03-09
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ICU MEDICAL, INC.
• Manufacturer Address: 4455 ATHERTON DR. SALT LAKE CITY UT 84123 US 84123

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-03-09