SYNCHON CX3 DELTA
Received Aug 1, 2012 · Event occurred Jul 9, 2012
Report 2050012-2012-01621 · MDR key 2678075
Device
Generic name
Analyzer, Chemistry, Micro, For Clinical Use
Manufacturer
Beckman Coulter, Inc.Catalog number
467501
Lot number
N/A
Product problems
- Fluid/Blood Leak
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED OBTAINING SUPPRESSED CALCIUM RESULTS AND SODIUM REFERENCE DRIFT RESULTS GENERATED ON THE SYNCHON CX3 DELTA CLINICAL SYSTEM. THE CUSTOMER RECALIBRATED THE INSTRUMENT AND RE-RUN QC WHICH WAS WITHIN RANGE. POST CALIBRATION, THE CUSTOMER NOTICED A TEASPOON OF CLEAR FLUID LEAKED OUT FROM CALCIUM ELECTRODE CHANNEL. PER CUSTOMER, NO ERRONEOUS PATIENT RESULTS WERE GENERATED. BECKMAN COULTER INC. CUSTOMER TECHNICAL SPECIALIST (CTS), REVIEWED MATERIAL SAFETY DATA SHEET (MSDS) AND CHEMICAL EXPOSURE PLAN IN THE LABORATORY AND ASSISTED THE CUSTOMER IN TROUBLESHOOTING THE EVENT. THE CTS DIRECTED THE CUSTOMER ON REPLACING CALCIUM ELECTRODE QUADRING. HOWEVER, THE ISSUE PERSISTED. CTS GENERATED SERVICE CALL. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LAB COAT AND GLOVES. THE CUSTOMER DID NOT COME IN CONTACT WITH THE FLUID AND DID NOT SEEK MEDICAL ATTENTION. NO EXPOSURE (SPRAYED OR SPLASHED) TO MUCOUS MEMBRANES OR OPEN WOUNDS WERE REPORTED. NO DEATH, INJURY OR CHANGES TO PATIENT TREATMENT OR RESULTS ARE ASSOCIATED WITH THIS EVENT. ON (B)(4) 2012, A FIELD SERVICE ENGINEER (FSE) VISITED THE SITE. THE FSE REMOVED AND REPLACED THE FOLLOWING: CALCIUM ELECTRODE ASSEMBLY. POTASSIUM AND CHLORIDE ELECTRODE BODY. RETAINER NUT. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENT PER ESTABLISHED PROCEDURES. ROUTINE SERVICE CALL RESOLVED THE ISSUE. THE CAUSE OF THE EVENT WAS A HAIRLINE FRACTURE IN THE RETAINER NUT.
Additional Manufacturer Narrative
(B)(4).