STATSPINEXPRESS 4 CENTRIFUGE

Additional Manufacturer Narrative

A BECKMAN COULTER CUSTOMER TECHNICAL SUPPORT (CTS) SPECIALIST ASSISTED CUSTOMER OVER THE PHONE. THE CUSTOMER STATED THAT THE STATSPIN EXPRESS 4 CENTRIFUGE EXPLODED, PRODUCING LOUD GUNSHOT SOUND AND THE CENTRIFUGE UNPLUGGED ITSELF FROM THE POWER OUTLET. THE CUSTOMER STATED THE ROTOR BROKE DURING OPERATION AND THE BROKEN PIECES FLEW WITHIN THE CENTRIFUGE AND ONE TUBE STUCK WITHIN THE CENTRIFUGE. THERE WAS NO REPORT OF INJURY OR EXPOSURE DUE BROKEN ROTOR. THE CUSTOMER PROVIDED PHOTOS OF BROKEN ROTOR. THE PHOTOS WERE REVIEWED AND CONFIRMED THAT THE BROKEN ROTOR WAS NOT THE ORIGINAL ROTOR SERIAL NUMBER (B)(6) SHIPPED WITH THE CENTRIFUGE; THE ROTOR WAS AN OLDER SERIAL NUMBER (B)(6). THE CUSTOMER WAS PROVIDED WITH STATSPIN CENTRIFUGE INSTRUCTION FOR USE (IFU) FOR ROTOR MAINTENANCE WHICH INDICATES TO INSPECT THE ROTOR WHEN REACHING 50,000 SPIN CYCLES AND WRENCH LIGHT TURNS ON. THE CTS NOTIFIED CUSTOMER THEY NEED TO REPLACE THE ROTOR. THE CUSTOMER ORDERED REPLACEMENT ROTOR TO RESOLVE THE ISSUE. SECTION B: CORRECTION TO DATE OF EVENT. THE BECKMAN COULTER INTERNAL IDENTIFIER IS (B)(4).

Additional Manufacturer Narrative

A BECKMAN COULTER CUSTOMER TECHNICAL SUPPORT (CTS) SPECIALIST ASSISTED CUSTOMER OVER THE PHONE. THE CUSTOMER STATED THAT THE STATSPIN EXPRESS 4 CENTRIFUGE EXPLODED, PRODUCING LOUD GUNSHOT SOUND AND THE CENTRIFUGE UNPLUGGED ITSELF FROM THE POWER OUTLET. THE CUSTOMER STATED THE ROTOR BROKE DURING OPERATION AND THE BROKEN PIECES FLEW WITHIN THE CENTRIFUGE AND ONE TUBE STUCK WITHIN THE CENTRIFUGE. THERE WAS NO REPORT OF INJURY OR EXPOSURE DUE BROKEN ROTOR. THE CUSTOMER WAS PROVIDED WITH STATSPIN CENTRIFUGE INSTRUCTION FOR USE (IFU) FOR ROTOR MAINTENANCE AND REPLACEMENT GUIDANCE. THE CTS NOTIFIED CUSTOMER THEY NEED TO REPLACE THE ROTOR TO RESOLVE THE ISSUE. SECTION A2, A4 AND A5: INFORMATION NOT PROVIDED BY CUSTOMER. INITIAL REPORTER PHONE NUMBER IS (B)(6). THE BECKMAN COULTER INTERNAL IDENTIFIER IS CASE-(B)(4).

Description of Event or Problem

THE CUSTOMER REPORTED THE STATSPIN EXPRESS 4 CENTRIFUGE, EXPLODED, PRODUCING A L LOUD GUNSHOT SOUND AND PARTS FLEW OFF AND ROTOR BROKEN PIECES SHATTER INSIDE THE CENTRIFUGE. ALTHOUGH THE ROTOR BROKE AND PIECE FLEW, THE PARTS WERE CONTAINED WITHIN THE EXPRESS 4 CENTRIFUGE. THERE WAS NO INJURY OR EXPOSURE DUE TO BROKEN ROTOR PIECES. THE CUSTOMER NOTED APPROXIMATELY SIX TUBES WERE INSIDE, WITH A BROKEN BARRICOR TUBE STILL LODGED WITHIN THE CENTRIFUGE THAT COULD NOT BE REMOVED. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED TO THIS EVENT.