BD KIESTRA¿ INOQULA+¿ TLA
Report
- Report Number
- 3010141591-2018-00001
- Event Type
- Injury
- Date Received
- January 15, 2019
- Date of Event
- December 26, 2018
- Report Date
- April 16, 2019
- Manufacturer
- BD KIESTRA LAB AUTOMATION
- Product Code
- JTC
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
H.6. INVESTIGATION SUMMARY: ON 26-DEC-2018 A REGIONAL BD FIELD SERVICE REPRESENTATIVE WAS DISPATCHED FOR CORRECTIVE MAINTENANCE. WHEN ON SITE, THE CUSTOMER INFORMED THE FIELD SERVICE REPRESENTATIVE THAT A LOUD THUMPING NOISE WAS COMING FROM THE PROCEEDA CONVEYOR SYSTEM OCCASIONALLY. THE FIELD SERVICE REPRESENTATIVE REMOVED THE PANELS IN THE AREA WHERE THE NOISE WAS COMING FROM TO INVESTIGATE AND DIAGNOSE THE CAUSE OF THE NOISE. THE FIELD SERVICE REPRESENTATIVE CHECKED THE BEARINGS AND DRIVE BELT OF THE CONVEYOR MOTOR BECAUSE THE NOISE SEEMED TO COME FROM THAT AREA. WHILE THE FIELD SERVICE REPRESENTATIVE TRIED TO FIND THE SOURCE OF THE NOISE HIS FINGER WAS CAUGHT IN THE MOTOR PULLEY SYSTEM WHERE HIS FINGER GOT WRAPPED AROUND THE PULLEY. THE FIELD SERVICE REPRESENTATIVE WAS SENT TO THE ER FOR MEDICAL ATTENTION. THERE THE FIELD SERVICE REPRESENTATIVE WAS TOLD BY THE DOCTORS THAT HIS SEVERED FINGER COULD NOT BE SAVED WHICH RESULTED IN LOSS OF THE TOP PART OF THE LEFT HAND POINTER FINGER. THE FIELD SERVICE REPRESENTATIVE WAS TREATED AND RELEASED FROM THE HOSPITAL TO RECOVER AT HOME. THE CUSTOMERS¿ LAB EMPLOYEE CLEANED THE INCIDENT AREA AND PUT THE PANELS BACK ON THE SYSTEM. AFTER THIS, THE TECHNICAL INSTRUMENT MANAGER OF BD WAS CONTACTED TO ASK IF IT WAS OK TO RUN THE SYSTEM AGAIN, AND ONCE VERIFIED IT WAS SAFE TO DO SO, THEY WERE GIVEN THE CONFIRMATION TO RETURN IT BACK TO OPERATION. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH THIS ISSUE. INVESTIGATION CONCLUSION: THE INCIDENT WAS INSTANTLY REPORTED BY THE EHS MANAGER TO MARYLAND OCCUPATIONAL SAFETY AND HEALTH VIA A PHONE CALL ON 26-DEC-2018. THE INVOLVED FIELD SERVICE REPRESENTATIVE WAS FULLY TRAINED FOR WORKING ON THE SYSTEM(S). THE TRAININGS INCLUDED, AMONG OTHERS, TIER I AND II AND PROCEED A SERVICE GUIDE (KLAFS0006). THE BD KIESTRA INSTRUMENTS HAVE THE FOLLOWING PHYSICAL AND PROCEDURAL SECURITY PRECAUTIONS IN PLACE TO MITIGATE SIMILAR INCIDENTS: ROTATING PARTS ARE PROTECTED WITH A FRONT PANEL WHICH IS BOLTED TO THE FRAME OF THE PROCEEDA THROUGH HEX SOCKET SCREWS. THE PANEL INCLUDES WARNING STICKERS FOR MOVING PARTS AND CRUSH HAZARD. THE EMERGENCY STOP SWITCH IS WITHIN ARM'S REACH. AT THE TIME OF THE INCIDENT, MAINTENANCE PROCEDURE KLAFS0006 - PROCEEDA SERVICE GUIDE-REV. 03 WAS RELEASED AND EFFECTIVE WHICH STIPULATES ABOUT CAUTIONS, WARNINGS, SAFETY PRECAUTIONS AND A LOCKOUT/TAGOUT PROCESS. AS AN IMMEDIATE ACTION, GLOBAL TECHNICAL SERVICES SENT A FIELD SAFETY NOTICE TO THE BD ASSOCIATES OF THE SERVICE ORGANIZATION TO HEIGHTEN AWARENESS AND ATTENTION TO THE SAFETY INSTRUCTIONS. AFTER CONSULTING WITH REGULATORY COMPLIANCE, IT WAS CONFIRMED THAT A SITUATION ANALYSIS WAS NOT NEEDED. A CAPA INITIATION AND DETERMINATION WAS WRITTEN TO ADDRESS THE INCIDENT. THE SEVERITY RANKING WAS SET AS SEVERE (S4) AND THE OCCURRENCE WAS SET AS IMPROBABLE (O1), RESULTING IN MEDIUM RISK AND IT WAS DECIDED TO INITIATE A CAPA (#892159). ROOT CAUSE DESCRIPTION: TO BE ABLE TO DETERMINE THE SOURCE OF THE NOISE, THE PANELS WERE OPENED BY THE FIELD SERVICE REPRESENTATIVE WHILE THE INSTRUMENT WAS RUNNING. THE FIELD SERVICE REPRESENTATIVE WAS FULLY TRAINED ON MAINTENANCE AND SAFETY PRECAUTIONS OF THE PROCEEDA; HOWEVER, THE RISK TO OPEN THE PANELS WAS DELIBERATELY TAKEN. THERE WAS NO MALFUNCTION OF THE INSTRUMENT THAT CAUSED THE INCIDENT AND NO GAP IN INSTRUCTIONS OR A PROCEDURAL SHORTCOMING THAT COULD BE RELATED TO THE INCIDENT. RATIONALE: AS PER PROCEDURE CPR-028 REV.15, THE ISSUE IS RANKED AS MEDIUM AND A DECISION WAS MADE TO INITIATE A CAPA, (B)(4)- FIELD SERVICE ENGINEER (FSE) INJURED DURING SERVICE ACTIVITIES.
CORRECTION: ADVERSE TYPE: ADVERSE EVENT.
IT WAS REPORTED THAT WHILE ATTEMPTING TO MAKE REPAIRS TO A BD KIESTRA¿ INOQULA+¿ TLA A FIELD SERVICE ENGINEER UNSCREWED AN INSTRUMENT PANEL OF THE COMPONENT PROCEED TLA 6 CONVEYOR SYSTEM WHILE THE INSTRUMENT WAS STILL IN OPERATION. THE FIELD SERVICE ENGINEER THEN REACHED INSIDE A PORTION OF THE INSTRUMENT NOT ACCESSIBLE DURING ROUTINE USE AND BEGAN TO ASSESS THE MOVING BEARINGS AND DRIVE BELT OF THE CONVEYOR MOTOR. THE FIELD SERVICE ENGINEER'S LEFT HAND BECAME CAUGHT IN THE DRIVE BELT AND WAS PULLED INTO THE INSTRUMENT'S MOTOR PULLEY SYSTEM WHICH CUT OFF THE TOP PORTION OF THEIR LEFT POINTER FINGER. THE FIELD SERVICE ENGINEER WAS TAKEN TO THE EMERGENCY DEPARTMENT FOR TREATMENT WHERE THEY WERE INFORMED THE DISMEMBERED PORTION OF THEIR FINGER COULD NOT BE REATTACHED. THE PATIENT WAS REFERRED TO A HAND SPECIALIST FOR FURTHER TREATMENT AND DISCHARGED TO RECOVER AT HOME.
IT WAS REPORTED THAT WHILE ATTEMPTING TO MAKE REPAIRS TO A BD KIESTRA¿ INOQULA+¿ TLA A FIELD SERVICE ENGINEER UNSCREWED AN INSTRUMENT PANEL OF THE COMPONENT PROCEEDA TLA 6 CONVEYOR SYSTEM WHILE THE INSTRUMENT WAS STILL IN OPERATION. THE FIELD SERVICE ENGINEER THEN REACHED INSIDE A PORTION OF THE INSTRUMENT NOT ACCESSIBLE DURING ROUTINE USE AND BEGAN TO ASSESS THE MOVING BEARINGS AND DRIVE BELT OF THE CONVEYOR MOTOR. THE FIELD SERVICE ENGINEER'S LEFT HAND BECAME CAUGHT IN THE DRIVE BELT AND WAS PULLED INTO THE INSTRUMENT'S MOTOR PULLEY SYSTEM WHICH CUT OFF THE TOP PORTION OF THEIR LEFT POINTER FINGER. THE FIELD SERVICE ENGINEER WAS TAKEN TO THE EMERGENCY DEPARTMENT FOR TREATMENT WHERE THEY WERE INFORMED THE DISMEMBERED PORTION OF THEIR FINGER COULD NOT BE REATTACHED. THE PATIENT WAS REFERRED TO A HAND SPECIALIST FOR FURTHER TREATMENT AND DISCHARGED TO RECOVER AT HOME.
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. BD KIESTRA¿ INOQULA+¿ TLA DEVICE SAFETY STATEMENT: BD KIESTRA HAS TAKEN THE FOLLOWING PHYSICAL AND PROCEDURAL SECURITY PRECAUTIONS TO MITIGATE SIMILAR INCIDENTS: ROTATING PARTS ARE PROTECTED WITH A FRONT PANEL WHICH IS BOLTED TO THE FRAME OF THE PROCEEDA THROUGH HEX SOCKET SCREWS. PANEL INCLUDES WARNING STICKERS FOR MOVING PARTS AND CRUSH HAZARD. EMERGENCY STOP SWITCH WITHIN ARM'S REACH. CURRENTLY, AND AT THE TIME OF THE INCIDENT, MAINTENANCE PROCEDURE KLAFS0006 - PROCEEDA SERVICE GUIDE REV. 03 WAS RELEASED AND EFFECTIVE WHICH SPEAKS ABOUT CAUTIONS, WARNINGS, SAFETY PRECAUTIONS AND A LOCKOUT/TAGOUT PROCESS.
IT WAS REPORTED THAT WHILE ATTEMPTING TO MAKE REPAIRS TO A BD KIESTRA¿ INOQULA+¿ TLA A FIELD SERVICE ENGINEER UNSCREWED AN INSTRUMENT PANEL OF THE COMPONENT PROCEEDA TLA 6 CONVEYOR SYSTEM WHILE THE INSTRUMENT WAS STILL IN OPERATION. THE FIELD SERVICE ENGINEER THEN REACHED INSIDE A PORTION OF THE INSTRUMENT NOT ACCESSIBLE DURING ROUTINE USE AND BEGAN TO ASSESS THE MOVING BEARINGS AND DRIVE BELT OF THE CONVEYOR MOTOR. THE FIELD SERVICE ENGINEER'S LEFT HAND BECAME CAUGHT IN THE DRIVE BELT AND WAS PULLED INTO THE INSTRUMENT'S MOTOR PULLEY SYSTEM WHICH CUT OFF THE TOP PORTION OF THEIR LEFT POINTER FINGER. THE FIELD SERVICE ENGINEER WAS TAKEN TO THE EMERGENCY DEPARTMENT FOR TREATMENT WHERE THEY WERE INFORMED THE DISMEMBERED PORTION OF THEIR FINGER COULD NOT BE REATTACHED. THE PATIENT WAS REFERRED TO A HAND SPECIALIST FOR FURTHER TREATMENT AND DISCHARGED TO RECOVER AT HOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 44260 | BD KIESTRA¿ INOQULA+¿ TLA | MICROBIAL SPECIMEN INOCULATION/STREAKING INSTRUMENT | JTC | BD KIESTRA LAB AUTOMATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention| S |