POWER EXPRESS

Additional Manufacturer Narrative

DATE OF BIRTH OR AGE, GENDER,WEIGHT, RACE, ETHNICITY: CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, SEX, WEIGHT, ETHNICITY OR RACE. AN ADVERSE EVENT THAT OCCURRED ON (B)(6) 2019 WAS REPORTED TO A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WHILE ON ASSIGNMENT AT A CUSTOMER SITE ON (B)(6) 2019. WHILE CORRECTING A TRANSFER ERROR OF A TUBE FROM THE OUTER LOADING ARM TO THE SHUTTLE VESSEL, A STAFF MEMBER GRABBED FROM BEHIND THROUGH THE STILL OPEN REAR SLIDING DOOR TO REMOVE THE INCORRECTLY PLACED TUBE. THE DOOR SUDDENLY CLOSED, TRAPPING THEIR HAND. THE CUSTOMER REPORTED THAT THEY HAD THEIR HAND TRAPPED IN POWER EXPRESS 5K STORAGE WHILE TRYING TO REMOVE INCORRECTLY PLACED TUBE. THE FAILURE MODE USE ERROR. THE INJURED STAFF DID NOT PERFORM ERROR RECOVERY AS PER PROCEDURE. PER POWER PROCESSOR IFU (PN-B01683A), CHAPTER 4 ERROR RECOVERY PROCEDURE, CAUTION STATEMENT STATES THAT, ¿EVEN WHEN THE SYSTEM IS IN PAUSE MODE, THE AIR SYSTEM IS STILL ACTIVE AND APPLYING A CONSTANT AIR PRESSURE TO VARIOUS ASSEMBLY COMPONENTS. THIS MAY CAUSE UNEXPECTED MOVEMENT OF ASSEMBLY COMPONENTS IN VARIOUS POWER PROCESSOR MODULES, CREATING A POSSIBLE MOVING PART OR PINCH HAZARD.¿ BECKMAN COULTER INTERNAL IDENTIFIER: (B)(4).

Description of Event or Problem

AN ADVERSE EVENT WAS REPORTED BY A CUSTOMER TO BECKMAN COULTER. WHILE CORRECTING A TRANSFER ERROR OF A TUBE FROM THE OUTER LOADING ARM TO THE SHUTTLE VESSEL, A STAFF MEMBER GRABBED FROM BEHIND THROUGH THE STILL OPEN REAR SLIDING DOOR TO REMOVE THE INCORRECTLY PLACED TUBE. THE DOOR SUDDENLY CLOSED, TRAPPING THEIR HAND. THE CUSTOMER REPORTED HAD THEIR HAND TRAPPED IN POWER EXPRESS 5K STORAGE WHILE TRYING TO REMOVE INCORRECTLY PLACED TUBE.