POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE, MODEL:
Received Apr 23, 2019 · Event occurred Mar 26, 2019
Report 2050012-2019-01071 · MDR key 8540720
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Device Handling Problem
- Adverse Event Without Identified Device or Use Problem
- Device Handling Problem
Patient
Not reported
- Abrasion
- Abrasion
Narrative
Additional Manufacturer Narrative
NO PATIENT INVOLVEMENT. CUSTOMER WAS INJURED WHILE PERFORMING ROUTINE TROUBLESHOOTING. CUSTOMER RECEIVED A PRECAUTIONARY TETANUS SHOT, WITH NO FURTHER MEDICAL ATTENTION REQUIRED. BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, IT DETERMINES THAT THE CUSTOMER FAILED TO FOLLOW IFU INSTRUCTION FOR ERROR RECOVERY AND TROUBLESHOOTING THE DECAPPER MODULE. PER POWER PROCESSOR DECAPPER AND RECAPPER MODULES INSTRUCTION FOR USE (IFU), PN-A97252AC, CHAPTER 3, ERROR RECOVERY PROCEDURES, PAGE 3-1, A CAUTION STATEMENT STATES THAT, ¿EVEN WHEN THE DECAPPER MODULE IS IN PAUSE MODE, THE AIR SYSTEM IS STILL ACTIVE AND APPLYING A CONSTANT AIR PRESSURE TO THE CAP REMOVAL AIR CYLINDERS. THIS MAY CAUSE UNEXPECTED MOVEMENT OF THE CAP REMOVAL AIR CYLINDERS WHEN RESOLVING JAMMED OBJECT ERRORS AT THE DECAPPER MODULE. USE CAUTION WHEN RESOLVING JAMMED OBJECT ERRORS AT THE DECAPPER MODULE.¿ THE FAILURE MODE WAS CONFIRMED TO BE CUSTOMER USE ERROR. BECKMAN COULTER INTERNAL IDENTIFIER IS CASE-(B)(4).
Description of Event or Problem
A CUSTOMER REPORTED AN ADVERSE EVENT WITH RELATION TO A POWER PROCESSOR TRACK ASSEMBLY, SERIAL NUMBER: (B)(4). THE CUSTOMER REPORTED A TECHNICIAN PERFORMING MAINTENANCE ON THE DECAPPER, AND THAT THE DECAPPER MOVED AFTER A TECHNICIAN FREED A STUCK PUCK. THE TECHNICIAN DURING MAINTENANCE PUNCTURED THEIR GLOVE AND THE SKIN OF THE RING FINGER ON THE LEFT HAND. THE INJURED PERSON WENT TO THE EMERGENCY DEPARTMENT AND RECEIVED A TETANUS SHOT. THE INJURED PERSON DID NOT RECEIVE FURTHER TREATMENT FOR THE INJURY. THE INJURED PERSON WAS NOT PUT ON MEDICAL LEAVE DUE TO THE INJURY.