TELEFLEX MEDICAL ARROW INTERNATIONAL FIBEROPTIX ULTRA IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC
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Model Number 8 IAB: 8FR 40CC |
Device Problems
Antenna, failure of (1029); Leak/Splash (1354); Material Rupture (1546); Rupture, cause unknown (1548); Device Contamination with Body Fluid (2317)
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Patient Problems
Ischemia (1942); Brain Injury (2219)
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Event Date 11/17/2018 |
Event Type
Death
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Event Description
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Iabp suddenly alarmed "pump failure" with no obvious source.There were a few microscopic speck of blood in the tube.Iabp was clamped.Saline was injected (<10 cc) and air was injected to inflated balloon and a small leak from balloon at the tip of catheter was noted c/w balloon rupture.Second catheter balloon rupture twice on two consecutive days (same pt).Unk if there was a failure in the catheter or the pump.
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Search Alerts/Recalls
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