OtherDSP
TERAFLEX IABP
Received Jun 9, 2026 · Event occurred Jun 3, 2026
Report MW5189052 · MDR key 25445675
Device
Generic name
System, Balloon, Intra-aortic And Control
Lot number
18F25J0111
Product problems
- Gas/Air Leak
Patient
51 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- MW5189051.