STA COMPACT HEMOSTASIS SYSTEM
Received Sep 7, 2004 · Event occurred Aug 7, 2004
Report 2245451-2004-00001 · MDR key 5690864
Device
Generic name
Automated Blood Coagulation Analyzer
Manufacturer
Diagnostica Stago, Inc.Model number
STA COMPACTCatalog number
56602
Lot number
NA
Product problems
- Component(s), broken
- Crack
- Valve(s), failure of
- Device Operates Differently Than Expected
- Component(s), broken
- Valve(s), failure of
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE NIGHT SHIFT AT A HOSPITAL CLINICAL LABORATORY REPORTED THAT THE STA COMPACT BLOOD COAGULATION ANALYZER WAS NOT FUNCTIONING AS EXPECTED. THE EQUIPMENT WAS TAKEN OUT OF SERVICE UNTIL A COMPANY REPRESENTATIVE WAS ABLE TO PERFORM A REPAIR. THE FIELD SERVICE ENGINEER FOUND A VERY SMALL CRACK IN A VALVE WHICH WAS REPLACED (SUSPECT PART WAS RETURNED TO COMPANY FOR EVALUATION). THE FACILITY REPORTED THAT THERE WAS NO INJURY TO ANY PATIENTS OR HOSPITAL PERSONNEL. THE VALVE FROM THE DEVICE HAS BEEN CHECKED BY THE MANUFACTURER. THE PRESENCE OF A SMALL CRACK IN THE VALVE WAS CONFIRMED. THIS COMPONENT DOES NOT HAVE A HISTORY OF CRACKING IN THIS MANNER. EFFORTS WERE MADE, USING THE SUBJECT VALVE AND SIMILAR VALVES WITH VARIOUS DEFECTS, TO MIMIC THE HOSPITAL'S MALFUNCTION EXPERIENCE. BECAUSE THE RESULTS COULD NOT BE DUPLICATED, IT IS NOT COMPLETELY CERTAIN THAT THIS MALFUNCTION AND THIS CRACKED COMPONENT ARE DIRECTLY LINKED. THIS EVENT IS CONSIDERED AN ISOLATED OCCURRENCE.