INTRA-AORTIC BALLOON
Received May 7, 2026 · Event occurred May 4, 2026
Report MW5187874 · MDR key 25113945
Device
Generic name
System, Balloon, Intra-aortic And Control
Catalog number
IAB-05840-LWS-SC
Lot number
18F25K0006
Patient
70 YR · Male
- Insufficient Information
Narrative
Description of Event or Problem
PATIENT REQUIRED INSERTION OF INTRA-AORTIC BALLOON PUMP. THE FIBER OPTIC SENSOR WAS ZEROED OUTSIDE THE BODY; ALL OF THE REQUIRED CHECKMARKS WERE GREEN. ON THE PUMP SCREEN, THE FIBER OPTIC SENSOR SHOWED THAT IT WAS ZEROED AT 10:03 A.M. THE PUMP WAS STARTED ONCE ALL THE CABLES WERE CONNECTED AND THE PHYSICIAN ORDERED THE PUMP STARTED. THE FIBER OPTIC SENSOR THEN SHOWED THAT IT WAS NOT ZEROED. THE MAIN SCREEN AND THE ZERO MENU SHOWED THAT IT WAS NOT ZEROED. THE BALLOON PUMP ARTERIAL PRESSURE WAS 40 POINTS OFF OF THE RADIAL ART LINE AND NON-INVASIVE PRESSURE. TELEFLEX WAS CONTACTED, AND WE RECALIBRATED THE ARTERIAL LINE MANUALLY. TELEFLEX IS SENDING A RETURN KIT FOR THE CATHETER TO BE RETURNED AND INVESTIGATED ONCE OUT OF THE PATIENT, AND THEY ASKED THAT THE PUMP BE SENT TO BIOMEDICAL WHEN ABLE.