inforMED
MalfunctionCIX

OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER

Received Nov 25, 2011 · Event occurred Oct 24, 2011

Report 2050012-2010-08061 · MDR key 2348496

Device

Generic name

Bromcresol Green Dye-binding, Albumin

Model number

AU5431

Catalog number

6196000

Lot number

N/A

Product problems

  • Air Leak
  • Leak/Splash
  • Pressure Problem

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

THE CUSTOMER POWERED THE UNIT OFF UPON NOTICING THE SMOKE. A BCI FIELD SERVICE ENGINEER (FSE) INVESTIGATED THE SMOKE AND CONCLUDED THAT THE CPU OF (B)(4) PC TO BE DEFECTIVE. FSE INSTALLED NEW COMPUTER, CLEANED CUVETTE, CALIBRATED AND QC TESTED THE UNIT. FSE VERIFIED ALL REPAIRS PER ESTABLISHED PROCEDURES AND ALL RESULTS MEET PUBLISHED PERFORMANCE SPECIFICATIONS.

Description of Event or Problem

THE CUSTOMER CONTACTED NOTICED A LEAK UNDERNEATH THE OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER LEAKED DURING RELOCATION OF THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LAB COAT, EYE PROTECTION, 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 RESULT OR TREATMENT ARE ASSOCIATED WITH THIS EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND NOTED THE SYSTEM WAS UNDERGOING A LOCATION MOVE AND EXPERIENCED A LEAK DUE TO FAILED WASTE PUMP. A SECONDARY PUMP ALSO LEAKED, WHICH MAY HAVE BEEN DUE TO BACK PRESSURE FROM THE INSTRUMENT, PER PRODUCT SPECIALIST. DRAIN TERMINALS SET UP BY PLUMBER DURING INSTRUMENT MOVE ARE EXPELLING AIR, WHICH MAY HAVE DAMAGED THE TWO WASTE PUMPS. BOTH THE ORIGINAL AND PUMP REPLACED FROM AN INACTIVE AU5400 SYSTEM (PAST WARRANTY AND QUESTIONED FUNCTIONAL) CAUSED LEAKS. THE ISSUE WAS RESOLVED WHEN REPLACED WITH A NEW WASTE PUMP. FSE REPLACED WASTE PUMP FOR THE SECOND TIME AND RAN THE DRAIN LINES INTO A BUCKET TO ELIMINATE BLOCKAGE AS A CAUSE FOR PUMP FAILURE. THE PUMP RAN A FULL W1 WITHOUT FAILURE. FSE THEN RE-ATTACHED DRAIN LINES TO DRAIN MANIFOLD IN FLOOR AND RAN ANOTHER W1 WITHOUT THE PUMP BACKING UP. IT WOULD SEEM THAT THE INITIAL PUMPS BORROWED FROM THE INACTIVE INSTRUMENT WERE FAULTY. ALL PUMPS WERE REPLACED. THE FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES. RESULTS MEET PUBLISHED PERFORMANCE SPECIFICATIONS. SYSTEM VALIDATION DOCUMENTED IN CUSTOMER QC RECORD.