EXPRESS 4 CENTRIFUGE
Received Feb 24, 2026 · Event occurred Jun 5, 2024
Report 2050012-2026-00013 · MDR key 24437443
Device
Generic name
Centrifuges (micro, Ultra, Refrigerated) For Clinical Use
Manufacturer
Beckman Coulter, IncModel number
EXPRESS 4 CENTRIFUGECatalog number
X00-005531-001
Lot number
N/A
Product problems
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THE STATSPIN EXPRESS 4 CENTRIFUGE¿S ROTOR SHATTERED, PRODUCING SMOKE AND A BURNING SMELL. THE CUSTOMER CONFIRMED NO EXPOSURE, INJURIES OR DEATH WERE ASSOCIATED WITH THIS EVENT.
Additional Manufacturer Narrative
TROUBLESHOOTING, CONDUCTED BY THE CUSTOMER AND A BECKMAN CUSTOMER TECHNICAL SPECIALIST (CTS), CONFIRMED THE EXPRESS 4 ROTOR WAS BROKEN. THE CUSTOMER REPORTED THE LID REMAINED CLOSED AND NO PARTS ESCAPED THE CENTRIFUGE DURING THE INCIDENT. CTS RECOMMENDED CUSTOMER REPAIR OR REPLACEMENT OF THE ROTOR TO RESOLVE THE ISSUE. SECTION A2, A3, A4, AND A5: INFORMATION NOT PROVIDED BY CUSTOMER. BECKMAN COULTER INTERNAL IDENTIFIER IS (B)(4).
Additional Manufacturer Narrative
THE FOLLOWING SECTIONS WERE UPDATED: B1: CHANGED FROM PRODUCT MALFUNCTION TO A NOT REPORTABLE EVENT. H10: FOLLOWING ADDITIONAL REVIEW AND CONSULTATION WITH THE BECKMAN MEDICAL DIRECTOR ON FEBRUARY 25, 2026. IT WAS DETERMINED THAT THE NON-PATIENT SAFETY RELATED RISK FOR EXPOSURE TO PHYSICAL AND MECHANICAL ENERGY HAZARDS HAS AS A SEVERITY OF MINOR DAMAGE AND A PROBABILITY OF HARM (P2) AS OCCASIONAL. BASED ON THIS RISK ASSESSMENT, THE EVENT IS NOT REPORTABLE.