MULTILAB SERIES II ERGO-IDC
Received Dec 19, 2022 · Event occurred Nov 23, 2022
Report MW5113854 · MDR key 16015359
Device
Generic name
Monitor,ultrasonic,nonfetal
Manufacturer
Unetixs Vascular, IncModel number
11949-0000-01Catalog number
MULTILAB SERIES II ERGO-IDC
Product problems
- Inflation Problem
- Pressure Problem
Patient
76 YR · Male
- Air Embolism
- Cardiac Arrest
- Nausea
- Air Embolism
- Cardiac Arrest
- Nausea
Narrative
Description of Event or Problem
ON (B)(6) 2022- PATIENT TAKEN TO RADIOLOGY FOR ABI. FT TECH AND AGENCY TECH COMPLETING EXAM TOGETHER. ABI AIR LINE CONNECTED TO RIGHT-SALINE LOCK LOCATED IN RIGHT AC. ERROR RECOGNIZED WHEN CUFF WAS NOT INFLATING AND AIR WAS NOT REACHING MAXIMUM POINT. EXAM STOPPED AND LINES DISCONNECTED. PATIENT REPORTS FEELING NAUSEOUS THEN SUFFERS CARDIAC ARREST. PATIENT PLACED ON LEFT SIDE, LN TRENDELENBURG POSITION. CODE BLUE INITIATED. ON (B)(6) 2022 1452 CT CHEST WITHOUT CONTRAST: EXTENSIVE PORTAL VENOUS GAS IS IDENTIFIED THROUGHOUT THE LIVER WITH PATCHY GAS AND AIR-FLUID LEVELS WITHIN THE SUPERIOR AND INFERIOR VENA CAVA, RIGHT ATRIUM AND VENTRICLE, SUBCLAVIAN VEINS AND PULMONARY ARTERIES. A SMALL AMOUNT OF GAS IS PRESENT WITHIN THE AORTIC ARCH AS WELL. DIAGNOSIS HE UNDER WENT ABLS TODAY AND THERE WAS AN ERROR DURING THE TEST AND PRESSURIZED AIR WAS INJECTED INTO THE PERIPHERAL IV. THE PATIENT SUBSEQUENTLY HAD A CARDIAC ARREST SECONDARY TO MASSIVE IATROGENIC AIR EMBOLISM. - DOCUMENTED BY DR. (B)(6)/CC REVIEW OF INCIDENT RELATED TO MACHINE : ABI AIR-LINE MALE CONNECTOR EASILY FITS INTO BOTH THE INTENDED BLOOD PRESSURE CUFF AND THE SALINE HELPLOCK CONNECTED TO THE IV SITE.