HEMOCHRON JR.
Received Nov 6, 1995 · Event occurred Aug 24, 1995
Report 28387 · MDR key 28387
Device
Generic name
Microcoagulation Instrument
Manufacturer
Internation Technidyne Corp.Lot number
ACV027, ACV024
Product problems
- False Reading From Device Non-Compliance
Patient
NA
- Bleeding
Narrative
Description of Event or Problem
PT UNDERGOING A STENT PROCEDURE IN THE CATHETERIZATION LABORATORY WAS GIVEN A BOLUS OF HEPARIN BEFORE BEING RELEASED TO CARDIAC INTENSIVE CARE UNIT FOR FOLLOW-UP. THE ACTIVATED CLOTTING TIME WAS 295 SECONDS BY THE INSTRUMENT USED IN CATH LAB. USING A NEW SYSTEM FOR ACT'S, THE HEMOCHRON DEVICE, THE SIMULTANEOUSLY PERFORMED ACT WAS 189. THE DISCREPANCY CAUSED PERSONNEL TO REPEAT THE ACTIVATED CLOTTING TIME USING BOTH DEVICES 30 MINUTES LATER. THE PT WAS FOLLOWED BY LABORATORY PERSONNEL USING BOTH SYSTEMS SIMULTANEOUSLY. THE RESULT WAS TO DELAY THE REMOVAL OF THE ARTERIAL LINES UNTIL AFTER 6PM, AN APPROPRIATE ACTION. HAD CATH LAB & CICU RELIED UPON THE RESULTS OF THE DEVICE, THE ARTERIAL LINES WOULD HAVE BEEN REQUESTED TO HAVE BEEN REMOVED AT LEAST 1 1/2 HRS EARLIER.