CELL-DYN 3700 CS ANALYZER
Report
- Report Number
- 2919069-2008-00726
- Event Type
- Malfunction
- Date Received
- October 13, 2008
- Report Date
- September 23, 2008
- Manufacturer
- ABBOTT DIAGNOSTICS DIVISION
- Product Code
- GKZ
- PMA / PMN Number
- K980614
- Removal / Correction Number
- 2919069-12/1/09-005-C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.
(B)(4). EVALUATION RESULTS: PRODUCT MEETS RELIABILITY DATA. ABBOTT LABORATORIES RECEIVED AN INITIAL CUSTOMER COMPLAINT ALLEGING THE CELL-DYN INSTRUMENT DID NOT SIGNAL A WASTE FULL ALARM. ALTHOUGH THE ORIGINAL PART FOR THIS EVENT COULD NOT BE INVESTIGATED, THE INVESTIGATION OF THE REPORTED ISSUE DETERMINED THAT THE PART WAS IN USE GREATER THAN 2 YEARS. THE INVESTIGATION INTO RETURNED PARTS FROM THE FIELD SHOWED THAT ALL HAVE BEEN IN USE GREATER THAN 2 YEARS. IN-HOUSE INVESTIGATION OF THE RETURNED PARTS COULD NOT REPRODUCE THE OCCURRENCE OF THE INITIAL COMPLAINT. THERE EXISTS A POTENTIAL FOR THE WASTE CONTAINER TO OVERFLOW WITH LIQUID WASTE WHEN THE WASTE SENSOR FAILS AT THE END OF ITS LIFE CYCLE. THE WASTE OUTLET TUBE ASSEMBLY (LN 92161-02) HAS A LONG HISTORY OF BEING RELIABLE. THERE HAVE BEEN NO TRENDS IN THE PERFORMANCE OF THIS PART FROM A RELIABILITY PERSPECTIVE. IT HAS CONSISTENTLY MET RELIABILITY EXPECTATIONS. THE WASTE OUTLET TUBE ASSEMBLY HAS BEEN ON THE MARKET FOR OVER 10 YEARS, AND MEETS RELIABILITY EXPECTATIONS FOR THE CELL-DYN 1800 INSTRUMENT. IT CAN BE USED ON MULTIPLE CELL-DYN INSTRUMENT MODELS. A REVIEW OF THE CELL-DYN 1800 SYSTEM OPERATOR'S MANUAL, LIST NUMBER 07H80-01, REVISION E, SHOWED ADEQUATE COVERAGE OF BIOHAZARD EXPOSURE AND WASTE OVERFLOW AS WELL AS TROUBLESHOOTING INFORMATION. THE WASTE OUTLET TUBE ASSEMBLY IS PERFORMING AS DESIGNED. THE RELIABILITY WAS DETERMINED TO BE ACCEPTABLE, AND THE PRODUCT IS MEETING EXPECTED SAFETY PERFORMANCE AS ESTABLISHED IN THE PRODUCT RISK MANAGEMENT FILE. ALTHOUGH THE WASTE OUTLET TUBE ASSEMBLY MEETS THE RELIABILITY REQUIREMENT, THERE EXISTS A POTENTIAL FOR THE WASTE CONTAINER TO OVERFLOW WITH LIQUID WASTE IF THE PRODUCT FAILS AT THE END OF ITS LIFE EXPECTANCY. THIS IS THE FINAL REPORT.
(B)(4). EVALUATION, RESULTS: PRODUCT MEETS RELIABILITY DATA. ABBOTT LABORATORIES RECEIVED AN INITIAL CUSTOMER COMPLAINT ALLEGING THE CELL-DYN INSTRUMENT DID NOT SIGNAL A WASTE FULL ALARM. ALTHOUGH THE ORIGINAL PART FOR THIS EVENT COULD NOT BE INVESTIGATED, THE INVESTIGATION OF THE REPORTED ISSUE DETERMINED THAT THE PART WAS IN USE GREATER THAN 2 YEARS. THE INVESTIGATION INTO RETURNED PARTS FROM THE FIELD SHOWED THAT ALL HAVE BEEN IN USE GREATER THAN 2 YEARS. IN-HOUSE INVESTIGATION OF THE RETURNED PARTS COULD NOT REPRODUCE THE OCCURRENCE OF THE INITIAL COMPLAINT. THERE EXISTS A POTENTIAL FOR THE WASTE CONTAINER TO OVERFLOW WITH LIQUID WASTE WHEN THE WASTE SENSOR FAILS AT THE END OF ITS LIFE CYCLE. BASED ON THE INTENDED USE, THIS PART WILL WEAR OUT AND NEED PERIODIC REPLACEMENT AS IT IS IN CONTACT WITH BIOHAZARD MATERIAL AND CUSTOMER USAGE/HANDLING. IT CAN BE USED ON MULTIPLE CELL-DYN INSTRUMENT MODELS. NO PREVENTIVE MAINTENANCE SCHEDULE WAS IN PLACE. A REVIEW OF THE CELL-DYN SYSTEM OPERATORS MANUALS SHOWED ADEQUATE COVERAGE OF BIOHAZARD EXPOSURE AND WASTE OVERFLOW AS WELL AS TROUBLESHOOTING INFORMATION FOR POTENTIAL CAUSES. THE WASTE OUTLET TUBE ASSEMBLY IS PERFORMING AS DESIGNED. THE RELIABILITY AND SAFETY ISSUES WERE DETERMINED TO BE WITHIN ESTABLISHED FREQUENCY. A HEALTH HAZARD ASSESSMENT (HHA) DETERMINED A LOW HEALTH RISK, WHICH IS CONSISTENT WITH THE RISK MANAGEMENT FILE ASSOCIATED WITH THE PRODUCT ALTHOUGH, THE WASTE OUTLET TUBE ASSEMBLY MEETS THE RELIABILITY REQUIREMENT, THERE EXIST A POTENTIAL FOR THE WASTE CONTAINER TO OVERFLOW WITH LIQUID WASTE IF THE PRODUCT FAILS AT THE END OF ITS LIFE EXPECTANCY. THE WASTE OUTLET TUBE ASSEMBLY PART LIFE EXPECTANCY OF 2 YEARS IS NOT CURRENTLY IN OUR PRODUCT LABELING. THE PREVENTIVE ACTION WILL INVOLVE A LABEL CHANGE FOR THE WASTE OUTLET TUBE ASSEMBLY. WE ARE CHANGING OUR LABELING TO HAVE A PART REPLACEMENT SCHEDULE OF 6 MONTHS SO PARTS ARE REPLACED PRIOR TO THE END OF THE 2-YEAR LIFE FAILURE. THIS WILL HELP PREVENT OVERFLOW ISSUES CAUSED BY END OF LIFE PART FAILURE. THIS IS THE FINAL REPORT.
(B)(4). AN EXPANDED INVESTIGATION HAS BEEN CONDUCTED TO EVALUATE THIS ISSUE. THE INVESTIGATION OF THE RETURNED PARTS FROM THE FIELD SHOWED THAT THE PART HAS BEEN IN USE GREATER THAN TWO YEARS. ALTHOUGH, THE WASTE OUTLET TUBE ASSEMBLY MEETS THE RELIABILITY REQUIREMENT, THIS PART WILL WEAR OUT AND THERE EXISTS A POTENTIAL FOR THE WASTE CONTAINER TO OVERFLOW WITH LIQUID WASTE WHEN THE WASTE SENSOR FAILS AT THE END OF ITS LIFE CYCLE. THEREFORE; THE PART WILL NEED PERIODIC REPLACEMENT AS IT IS IN CONTACT WITH BIOHAZARD MATERIAL AND CUSTOMER USAGE/HANDLING. THE PART CAN BE USED ON MULTIPLE CELL-DYN INSTRUMENT MODELS. A REVIEW OF THE CELL-DYN SYSTEM OPERATORS MANUALS SHOWED ADEQUATE COVERAGE OF BIOHAZARD EXPOSURE AND WASTE OVERFLOW AS WELL AS TROUBLESHOOTING INFORMATION FOR POTENTIAL CAUSES. ABBOTT RECOMMENDED A REPLACEMENT SCHEDULE FOR THE WASTE LINE ASSEMBLY FOR THE CELL-DYN SYSTEMS. THE WASTE BOTTLE CABLE IS A SUBCOMPONENT OF THE WASTE LINE ASSEMBLY, CHANGING THE WASTE LINE ASSEMBLY WILL RESULT IN CHANGING THE WASTE BOTTLE CABLE. AS PART OF THE CORRECTIVE ACTION, A PRODUCT CORRECTION LETTER, (B)(4), WAS ISSUED TO ALL AFFECTED CUSTOMERS. IN THIS COMMUNICATION, ABBOTT RECOMMENDED REPLACING THE PART EVERY SIX MONTHS. AN UPDATE TO THE PRODUCT LABELING WILL BE ADDED AS WELL WITH REGARDS TO THIS RECOMMENDATION. A TAG THAT CAN BE AFFIXED TO THESE ITEMS WAS SENT WITH THE CUSTOMER LETTER. THIS TAG INCLUDES FIELDS TO RECORD INSTALLATION AND REPLACEMENT DATES. THE TAGS WILL ALSO BE INTRODUCED INTO REPLACEMENT ASSEMBLIES.
(B)(4).
THE ACCOUNT STATED THAT THE CELL-DYN 3700 ANALYZER'S WASTE SENSOR DOES NOT DETECT THAT THE WASTE CONTAINER IS FULL. THERE WERE NO DIRECT FLUID EXPOSURES OR INJURIES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CELL-DYN 3700 CS ANALYZER | AUTOMATED HEMATOLOGY ANALYZER | GKZ | ABBOTT DIAGNOSTICS DIVISION | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | WASTE OUTLET TUBE, LIST# 92161-02| WASTE OUTLET TUBE, LIST# 92161-02| WASTE OUTLET TUBE, LIST# 92161-02| WASTE OUTLET TUBE, LIST# 92161-02. LOT# UNK| WASTE OUTLET TUBE, LIST# 92161-02 |