AIA-2000
Report
- Report Number
- 8031673-2018-00371
- Event Type
- Malfunction
- Date Received
- May 2, 2018
- Date of Event
- April 3, 2018
- Report Date
- May 3, 2019
- Manufacturer
- TOSOH CORPORATION
- Product Code
- KHO
- PMA / PMN Number
- K971103
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S FACILITY TO ADDRESS THE REPORTED EVENT. FSE CONFIRMED LEAKING B/F WASH PROBE #1. FSE FOUND THE PURGE TUBE WAS POPPING OFF THE TOP OF THE PROBE AND IDENTIFIED THE CAUSE TO BE A SCREW CAUSING THE BACK PRESSURE. FSE REMOVED THIS SCREW AND REPLACED THE WASHING PROBE #1 ASSEMBLY. FSE CLEANED THE B/F INCUBATOR FROM THE ACCUMULATED WASH LIQUID, REMOVED AND CLEANED THE ROTOR, THE COVERS, AND LUBRICATED THE B/F ASSEMBLY. FSE THEN RAN THE TEST CUP MACRO TEST AND QUALITY CONTROLS (QC). THE CUP TEST FUNCTIONS WITHIN SPECIFICATION AND THE QC RESULTS WERE WITHIN ACCEPTABLE RANGE. THE AIA-2000 INSTRUMENT WAS PERFORMING AS INTENDED AND THE NO LEAKS WERE FOUND. NO FURTHER ACTION WAS REQUIRED BY THE FIELD SERVICE. THIS AIA-2000 INSTRUMENT WAS INSTALLED AT CUSTOMER FACILITY ON 28-JUN-2017. A COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL (B)(4) FROM 28-JUN-2017 THROUGH AWARE DATE (B)(6) 2018. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE AIA-2000 OPERATOR'S MANUAL, CHAPTER 6 SYSTEM OPERATION, UNDER MAINTENANCE ROUTINE OUTLINES PRIMING THE SUBSTRATE LINE AND FLUSHING THE WASH SOLUTION COULD OUTPUT ERRORS WITH B/F PROBES 1 TO 4: (1) PRIMING THE SUBSTRATE LINE PRIME THE SUBSTRATE LINE WITH THE SUBSTRATE. (2) FLUSH THE WASH SOLUTION. FLUSH OUT ANY WASH SOLUTION REMAINING IN THE WASH LINES. THE FOLLOWING ERROR MESSAGES APPEAR IF THE WASH SOLUTIONS ARE NOT PROPERLY FLUSHED. "2239: B/F PROBE 1 FLUSH FAILURE" APPEARS WHEN B/F PROBE 1 FLUSH FAILS. "2240: B/F PROBE 2 FLUSH FAILURE" APPEARS WHEN B/F PROBE 2 FLUSH FAILS. "2241: B/F PROBE 3 FLUSH FAILURE" APPEARS WHEN B/F PROBE 3 FLUSH FAILS. "2242: B/F PROBE 4 FLUSH FAILURE" APPEARS WHEN B/F PROBE 4 FLUSH FAILS. THESE MESSAGES INDICATE THAT AIR WAS NOT COMPLETELY FLUSHED FROM THE WASH SOLUTION LINES. IF ERRORS OCCUR, PRESS THE B/F PROBE KEY ON THE AIA-2000 SHEET KEY, OPEN THE COVER AND CHECK B/F UNIT FOR POSSIBLE CAUSES OF THE MALFUNCTION. AFTER THIS, CLICK PRIME WASH SOLUTION BUTTON ON THE OPERATION PANEL (TOOLBAR) TO REPEAT THE FLUSH PROCEDURE UNTIL THE LINES ARE FULL AND THE ERRORS STOP. CONTACT A TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVES IF ERROR MESSAGES STILL APPEAR AFTER FLUSHING 5 TIMES OR MORE. THE B/F WASH PROBES ARE DESIGNED TO DRAW THE WASH SOLUTION THAT WAS DISPENSED INTO THE WASH PORT. THE FOLLOWING ERROR MESSAGES APPEAR WHEN A PROBLEM OCCURS. "2235: B/F PROBE 1 SUCTION FAILURE" APPEARS WHEN B/F PROBE 1 SUCTION FAILS. "2236: B/F PROBE 2 SUCTION FAILURE" APPEARS WHEN B/F PROBE 2 SUCTION FAILS. "2237: B/F PROBE 3 SUCTION FAILURE" APPEARS WHEN B/F PROBE 3 SUCTION FAILS. "2238: B/F PROBE 4 SUCTION FAILURE" APPEARS WHEN B/F PROBE 4 SUCTION FAILS. IF THESE APPEAR, CHECK THE B/F WASH PROBE TIP FOR FOREIGN MATTER. IF CLOGGED, REFER TO THE B/F WASH PROBE TIP CLEANING PROCEDURES DESCRIBED IN CHAPTER 9: SECTION 9.2.1 CLEANING B/F WASH PROBES. CONTACT A TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVES IF MESSAGES STILL APPEAR AFTER THE B/F WASH PROBE TIP HAS BEEN CLEANED. THE MOST PROBABLE CAUSE OF THE REPORTED ISSUE WAS DUE TO A SCREW IN WASH WELL PROBE #1.
TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER: E2017013. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. CORRECTED DATA: IN THE PREVIOUS FOLLOW-UP #2 REPORT, THE DATES SHOULD HAVE BEEN 20-SEP-2018. DEVICE EVALUATION BY MANUFACTURER: THE WASH PROBE ASSEMBLY WAS RECEIVED FOR EVALUATION. FUNCTIONAL TESTING WAS PERFORMED ON THE PART AND FOUND THAT THERE WAS NO LEAKING NOTED ON THE WASH PROBE OR THE CONNECTED TUBING DURING PRIMING OR DURING PRECISION TESTING. THE PART PASSED FUNCTIONAL TESTING. THE REPORTED EVENT COULD NOT BE DUPLICATED. EVALUATION CODES: RESULTS: 213 NO DEVICE PROBLEM FOUND. CONCLUSION CODE: 67 NO PROBLEM DETECTED. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE PART FUNCTIONED AS INTENDED.
TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. THE 13-MONTH REVIEW IN THE INITIAL MDR INCORRECTLY WAS INCORRECTLY DOCUMENTED. IT SHOULD HAVE STATED: THIS AIA-2000 INSTRUMENT WAS INSTALLED AT CUSTOMER FACILITY ON 06-JUL-2017. A COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4) FROM 06-JUL-2017 THROUGH AWARE DATE 04-APR-2018. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD.
(B)(4).
H2. ADDITIONAL INFORMATION: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR SERIAL NUMBER (B)(4) WHICH CONFIRMED THAT THERE WERE NO NON-CONFORMANCES, FAILURES, DISCREPANCIES, OR MISSED STEPS DURING THE MANUFACTURING PROCESS THAT COULD BE RELATED TO THE REPORTED EVENT.
CORRECTED DATA: SECTION F6 AND G5 -THIS FOLLOW-UP #2 IS FOR A CORRECTION IN THE PREVIOUSLY SUBMITTED FOLLOW-UP #1 WHERE THE DATES IN THESE SECTIONS WERE INCORRECT. TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.
A CUSTOMER REPORTED THE B/F (BOUND / FREE) PROBE #1 WAS LEAKING ON THE AIA-2000 INSTRUMENT. THE CUSTOMER STATED CHECKED PROBE AND SAW THAT THE LINE GOING INTO THE PROBE WAS DETACHED. THE PROBED WAS REATTACHED AND THE ERROR RECURRED. CUSTOMER COULD NOT LOCATE THE SOURCE OF THE LEAK AS ALL TUBING LOOKED ATTACHED. CUSTOMER REQUESTED SERVICE. THE CUSTOMER IS UNABLE TO RUN PATIENT SAMPLES ON ALPHA-FETOPROTEIN (AFP). FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF AFP PATIENT RESULTS. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 322519 | AIA-2000 | AIA-2000 | KHO | TOSOH CORPORATION | AIA-2000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |