HEMOSAFE
Received Aug 5, 2013 · Event occurred Jul 17, 2013
Report 1000631067-2013-00001 · MDR key 3289583
Device
Product problems
- Thermal Decomposition of Device
- Loss of Power
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
HEMOSAFE MACHINE STARTING CAPACITOR AND WIRING BURNT NEXT TO COMPRESSOR CAUSING OVERALL LOSS OF POWER.
Additional Manufacturer Narrative
(B)(6) HOSPITAL EXPERIENCED A LOSS OF POWER LEADING TO THE NOTIFICATION OF THE PUGET SOUND BLOOD CENTER FIELD SERVICE ENGINEER (B)(6). ON ARRIVAL THE ENGINEER DISCOVERED VARIOUS BURNT PARTS AND MELTED WIRES. NO FIRE ALARMS WERE SOUNDED AS A RESULT OF THE BURNING PARTS, HOWEVER THE POTENTIAL FOR STARTING A FIRE STILL EXISTS. PARTS WERE REMOVED FROM ONE THE UNUSED PUGET SOUND HEMOSAFES TO REPLACE THE STARTING COMPONENTS AFFECTED BY THE INCIDENT. ALL MELTED WIRES WERE REMOVED AS WELL. UPON SERVICING, THE COMPRESSOR WAS FUNCTIONING NORMALLY FOR 14 HRS WITH THE EXCEPTION OF A MOMENTARY SPIKE IN AMPERAGE MEASURING 19-20 AMPS. SINCE THE PARTS WERE REPLACED, THERE ARE NO PROBLEMS STARTING THE UNIT.