5K STORAGE, POWER EXPRESS
Received Feb 11, 2021 · Event occurred Jan 20, 2021
Report 2050012-2021-00005 · MDR key 11319133
Device
Generic name
Radioassay, Vitamin B12
Manufacturer
Beckman CoulterModel number
5K STORAGE, POWER EXPRESSCatalog number
B36361
Lot number
PS201808002
Product problems
- Patient Device Interaction Problem
- Patient Device Interaction Problem
Patient
Not reported
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Additional Manufacturer Narrative
THE BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE 5K STOCKYARD SYSTEM, AND IDENTIFIED AN ISSUE WITH THE FS113 SENSOR. THE FSE REPORTED THAT THE SENSOR NEEDING REPLACEMENT WAS ALL THE WAY IN THE BACK OF THE INSTRUMENT AND THE ONLY WAY TO GET THERE IS THROUGH THE FRONT. THIS REQUIRES LYING FLAT ON THE GROUND FOR THE 1ST FLOOR OF THE STOCKYARD AND HAVE HIS HEAD AND BOTH ARMS INSERTED INTO THE INSTRUMENT THROUGH A 10-INCH OPENING WITH ARMS BEING EXTENDED ABOVE THE HEAD. WHILE IN THIS POSITION, THE FSE FELT A SHARP PAIN IN HIS LOWER BACK. THE FSE WENT TO THE ER WHERE HE WAS PRESCRIBED DIAZEPAM 5MG, CYCLOBENZAPRINE 10MG, AND PREDNISONE 20MG. HE IS ALSO RECEIVING THERAPY AND IS OUT OF WORK UNTIL (B)(6) 2021. THE CAUSE OF THE INJURY IS DUE TO THE AWKWARD POSITIONING OF THE BODY WHILE TROUBLESHOOTING. THE FSE RESOLVED THE SENSOR ISSUE BY REPLACEMENT OF THE TUBE SENSOR AND ELEVATOR GRIPPER, ADJUSTMENT OF THE RETRIEVAL SHUTTLE CUP TUBE SENSOR AND ALIGNMENT OF THE GRIPPER ASSEMBLY. UDI NUMBER NOT AVAILABLE. THE BECKMAN COULTER INTERNAL IDENTIFIER IS (B)(4).
Description of Event or Problem
A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) FELT A SHARP AND ACUTE PAIN IN HIS LOWER BACK DUE TO AWKWARD POSITIONING WHILE TROUBLESHOOTING A CUSTOMER'S PS113 ERROR IN 5K STOCKYARD SYSTEM THAT REQUIRED TO LIE FLAT ON THE GROUND FOR THE 1ST FLOOR OF THE STOCKYARD AND HAVE HIS HEAD AND BOTH ARMS INSERTED INTO THE INSTRUMENT THROUGH A 10-INCH OPENING AND ARMS BEING EXTENDED ABOVE HIS HEAD. THE FSE WENT TO THE EMERGENCY ROOM (ER) WHERE HE RECEIVED TREATMENT AND WAS PRESCRIBED DIAZEPAM 5MG, CYCLOBENZAPRINE 10MG, AND PREDNISONE 20MG.