STATSPINEXPRESS 4 CENTRIFUGE

Additional Manufacturer Narrative

THE CUSTOMER CONTACTED BECKMAN COULTER ON (B)(6) 2025 AFTER MEDWATCH REPORT #MW5164601 WAS SUBMITTED TO INFORM LEGAL MANUFACTURER, BECKMAN COULTER (BEC), OF THE EVENT. THE FOLLOWING INFORMATION WAS OBTAINED FROM SERVICEMAX CA-07502883: CUSTOMER NOTED TO BEC HOTLINE THE LID POPPED OFF DURING OPERATION. ADDITIONALLY, CUSTOMER ALSO INFORMED HOTLINE THAT NO BROKEN PIECES OF THE ROTOR OR PLATE ESCAPE THE EXPRESS 4 CENTRIFUGE. HOTLINE PROVIDED A RETURN MATERIAL AUTHORIZATION (RMA) TO HAVE THE CENTRIFUGE RETURNED TO BECKMAN COULTER FOR FURTHER EVALUATION. BECKMAN COULTER QUALITY ASSURANCE (QA) PERFORMED A FOLLOW UP WITH THE CUSTOMER ON (B)(6) 2025 TO OBTAIN CLARIFICATION DUE TO THE DISCREPANCY IN THE REPORTED EVENT IN MEDWATCH REPORT #MW5164601 AND WHAT WAS REPORTED TO BEC ON (B)(6) 2025 DOCUMENTED IN SERVICEMAX CA-07502883. THE REPORTED EVENT COMMUNICATED TO THE HOTLINE REPRESENTATIVE WAS REGARDING THE LID POPPING OFF, WHICH SEEMS TO DIFFER FROM THE INFORMATION NOTED IN THE MEDWATCH REPORT #MW5164601, WHICH MENTIONED A CENTRIFUGE EXPLOSION. THE CUSTOMER STATED, ¿THE FRONT CIRCUIT BOARD AND PANEL MADE A LOUD NOISE AND FLEW OFF THE CENTRIFUGE. PARTS IN THE CENTRIFUGE FLEW OFF AND THE TECH DESCRIBED IT AS AN EXPLOSION. IT WAS A LOUD NOISE AND PARTS FLEW OFF. HE WAS NOT HURT BUT HE HAD RINGING IN HIS EARS AFTER THE INCIDENT¿. QUALITY ASSURANCE (QA) INVESTIGATOR REQUESTED ADDITIONAL INFORMATION FROM REPAIR DEPOT. ON (B)(6) 2025, THE REPAIR DEPOT ACKNOWLEDGE THE EXPRESS 4 CENTRIFUGE IS RECEIVED. THE MANUFACTURING/PROCESS ENGINEERING MANAGER NOTED THE STATSPIN EXPRESS 4 APPEARED TO HAVE UNDERGONE VERY FREQUENT USE THROUGHOUT ITS THREE (3) YEARS OF BEING FIELDED. THERE WERE A LOT OF WEAR AND TEAR. PER SERVICE REPORT WO-(B)(4), ONE OF THE ROTOR PEG SCREWS BROKE OFF AND CAUSED DAMAGES TO THE METAL BOWL, THE SHIELD, THE LATCH ASSEMBLY AND THE FRONT BEZEL. THE REPAIR DEPOT REPAIRED THE ROTOR ASSEMBLY BY REPLACING THE ROTOR PLATE. THE REPAIR DEPOT ALSO REPLACED ALL THE DAMAGE HARDWARE PARTS, INCLUDING THE EXPRESS 4 BOWL, EXPRESS 4 SHIELD, BEZEL, EXPRESS 4 KEYPAD AND HARNESS INTERRUPT SWITCH, WHICH CAUSED BY THE BROKEN ROTOR PEG SCREW. THE PROBABLE CAUSE WAS IDENTIFIED AS BROKEN ROTOR PEG SCREW IN THE ROTOR ASSEMBLY. THE REPAIR DEPOT COMPLETED THE TESTING OF THE EXPRESS 4 CENTRIFUGE WITH NO ISSUES OR ERRORS. THE UNIT PASSED ALL ACCEPTANCE CRITERIA DEFINED IN THE REPAIR CHECKLIST AND FUNCTIONS AS EXPECTED. NO FURTHER ISSUE WAS OBSERVED. SECTION A2, A4 AND A5: INFORMATION NOT PROVIDED BY CUSTOMER. THE BECKMAN COULTER INTERNAL IDENTIFIER IS (B)(4).

Description of Event or Problem

PER MEDWATCH REPORT, #MW5164601, THE CUSTOMER REPORTED THE STATSPIN EXPRESS 4 CENTRIFUGE EXPLODED, MADE A LOUD BOOM AND PARTS FLEW OFF THE CENTRIFUGE AND PIECES WERE SHATTERED INSIDE THE CENTRIFUGE. THE CUSTOMER REPORTED A LOUD RINGING IN HIS EAR BUT NO INJURY AND NO REPORT OF TREATMENT.