TRANSONIC
Received May 7, 2021 · Event occurred Apr 20, 2021
Report 11789671 · MDR key 11789671
Device
Generic name
Flowmeter, Blood, Cardiovascular
Manufacturer
Transonic Systems Inc.Model number
HT110Catalog number
UNKNOWN
Lot number
HT110
Product problems
- Device Alarm System
- Protective Measures Problem
Patient
14235 DA
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
NO LOW FLOW ALARMS TRIGGERED BY R IJ ECMO FLOW PROBE. ALARM ISSUES: ALARM SET INCORRECTLY. PRIOR TO EVENT, STABLE R IJ ECMO FLOWS >1.3 AND STABLE L GROIN ECMO > 4.4 NOTED DURING MORNING HANDOFF REPORT WITH PM RN AND DURING "PRE-ROUNDS" WITH ALD RESIDENT. AROUND 0845 - NO FLOW ON R IJ ECMO CANNULA VISUALLY NOTICED WITH ANESTHESIOLOGIST DURING ICU ROUNDS, NO ALARMS AT THIS TIME. PERFUSIONIST ASSESSED AND REPORTED SEEING SEPARATION OF BLOOD/CLOT IN R IJ CANNULA. PATIENT HAS A KNOWN ATRIAL SEPTAL DEFECT (ASD). THROUGHOUT THE EVENT PATIENT WAS HEMODYNAMICALLY STABLE AND INTACT MENTAL STATUS. EMERGENT REMOVAL OF R IJ CANNULA PERFORMED BEDSIDE BY MD. PATIENT RECEIVED 30MCG EPINEPHRINE IV PUSH FOR CARDIAC SUPPORT AND 125MCG OF FENTANYL. PATIENT HEMODYNAMICALLY TOLERATED THE DECANNULATION. LOW FLOW ALARM OR NO FLOW ALARM WOULD HAVE BEEN USEFUL IN THIS SITUATION.