InjuryDPW
ARROW HEMOSONIC 100 SYSTEM
Received Jul 28, 2000
Report 1219856-2000-00184 · MDR key 287417
Device
Generic name
Hemosonic Monitoring System
Manufacturer
Arrow International, Inc.Model number
NACatalog number
HSM-00100
Lot number
UNK
Product problems
- Output, low
- Use of Device Problem
- Low Readings
Patient
UNKNOWN
- Pulmonary Edema
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE DEVICE WAS IN USE TO MONITOR A PT WITH AN ABDOMINAL AORTIC ANEURYSM USING ONLY TOTAL CARDIAC OUTPUT FROM THE MONITOR. THE PHYSICIAN DID NOT CONSIDER THE OTHER FACTORS SUCH AS SYSTEMIC VASCULAR RESISTANCE, CHANGES IN BLOOD FLOW, STROKE VOLUME, ETC. BASED ON ONLY THE CARDIAC OUTPUT READINGS, HE GAVE THE PT FLUIDS. AS A RESULT OF THE USER ERROR, THE PT DEVELOPED PULMONARY EDEMA. THE PT RECOVERED AND THERE WERE NO COMPLICATIONS.