STAT PROFILE PRIME PLUS ANALYZER SYSTEM
Received Sep 4, 2019 · Event occurred Aug 4, 2019
Report 1219029-2019-00047 · MDR key 8959572
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Misassembly During Maintenance/Repair
- Misassembly During Maintenance/Repair
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
DHR REVIEWS WERE PERFORMED INCLUDING AN ASSESSEMENT OF THE PRODUCTION, TESTING, AND RELEASE OF THE ANALYZER AND CONSUMABLES. NO ABNORMALITIES OR CONCERNS WERE OBSERVED. THE DHR INDICATED THAT THE RELEASED PRODUCT MET ALL SPECIFICATIONS. DURING THE FIELD SERVICE SUPPORT FOLLOW-UP VISIT, THE NOVA BIOMEDICAL TECHNICIAN DISCOVERED THAT THE REFERENCE CARTRIDGE WAS NOT SEATED. THE TECHNICIAN RESEATED THE REFERENCE SENSOR AND PRIMED THE FLUIDS. THE INSTRUMENT WAS CALIBRATED FOUR (4) TIMES AND CONTROLS WERE ANALYZED. THE CUSTOMER REPORTED THE REFERENCE PUMP TUBING WAS BEING PULLED TIGHTLY THROUGH THE PUMP DUE TO A DETACHED RETAINING COLLAR. HOWEVER, IT WAS DETERMINED THAT THE REFERENCE PUMP TUBING DID NOT CONTRIBUTE TO THE DISCREPANT RESULTS, BASED ON THE FACT THAT OTHER REFERENCE DEPENDENT RESULTS WERE NORMAL. TESTING OF A RETAINED SENSOR CARD FROM THE SAME LOT MET THE ACCEPTANCE CRITERIA AND NO ERRONEOUS RESULTS WERE OBSERVED.
Additional Manufacturer Narrative
DURING A SERVICE VISIT NOVA'S TECHNICIAN DISCOVERED THAT REFERENCE SENSOR WAS INSTALLED INCORRECTLY: THE SENSOR WAS NOT SEATED PROPERLY. INVESTIGATION IS ONGOING
Description of Event or Problem
CUSTOMER REPORTED DISCREPANT IONIZED CALCIUM RESULT USING NOVA STAT PROFILE PRIME PLUS ANALYZER, SN (B)(4) WHEN COMPARED TO OTHER PRIME PLUS ANALYZER. NO ADVERSE EVENT WAS REPORTED.