inforMED
OtherDSP

TERAFLEX IABP

Received Jun 9, 2026 · Event occurred Jun 3, 2026

Report MW5189051 · MDR key 25445565

Device

Generic name

System, Balloon, Intra-aortic And Control

Lot number

18F25J0111

Product problems

  • Gas/Air Leak

Patient

61 YR · Male

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

WHEN ATTEMPTING TO PLACE AN INTRAAORTIC BALLOON PUMP, IMMEDIATELY PUMP ALARMED LARGE HELIUM LOSS. A NEW CONSOLE WAS BROUGHT IN, BUT SAME ALARM WAS PRESENT. PT: 4582. DEVICE: 2946. REFERENCED REPORT- MW5189052.