FLEXLAB
Report
- Report Number
- 3010825766-2021-00011
- Event Type
- Malfunction
- Date Received
- December 10, 2021
- Report Date
- February 24, 2022
- Manufacturer
- INPECO SA
- Product Code
- CEM
- UDI-DI
- 07640172340004
- PMA / PMN Number
- K121012
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- 003
Narratives
THE INVESTIGATION IS ONGOING TO DETERMINE THE ROOT CAUSE AND TO IDENTIFY HOW TO FIX THE ISSUE. THE WBB MODULES ARE KEPT MONITORED.
THE INVESTIGATION IS ONGOING TO DETERMINE THE ROOT CAUSE AND TO IDENTIFY HOW TO FIX THE ISSUE. THE WBB MODULES ARE KEPT MONITORED.
THE INITIAL REPORT HAS BEEN SUBMITTED ON DECEMBER 10TH, 2021. ADDITIONAL INFORMATION: THE INVESTIGATION HAS BEEN COMPLETED. THE ROOT CAUSE OF THE SAMPLE SPILLAGE AT THE WIDE BELT BUFFER (WBB) EXIT HAS BEEN IDENTIFIED IN THE SPECIFIC TRAFFIC CONDITIONS, WORKFLOW AND LAYOUT CONFIGURATION PRESENT IN THIS SITE. TO SOLVE THE PROBLEM THE SPEED VALUES OF THE WBB BELTS WHICH CARRY THE CARRIERS FROM THE BUFFER TO THE MODULE PIT LANE HAVE BEEN MODIFIED TO IMPROVE THE CONFLUENCE OF THE CARRIERS ON THE TRACK. AFTER THIS CHANGE THE MODULES HAVE BEEN KEPT MONITORED AND NO FURTHER OCCURRENCES HAVE BEEN OBSERVED WHERE THE SAMPLE TUBES RETURN ON THE MODULE PIT LANE. NO ADDITIONAL ACTIONS ARE FORESEEN.
SAMPLE RESIDUES HAVE BEEN FOUND AT THE EXIT OF THE WIDE BELT CARRIER BUFFER MODULES (WBB) WHERE THE SAMPLE TUBES PREVIOUSLY PARKED IN THE MODULE BUFFER RETURNED ON THE PIT LANE. THE WIDE BELT CARRIER BUFFER MODULE IS A SAMPLE CARRIERS COLLECTOR THAT PROVIDES THE CAPABILITY TO RELIEVE THE TRACK WORKLOAD. THE SAMPLE SPILLAGE MAY HAVE CAUSED THE CONTAMINATION OF OTHER UNCAPPED SAMPLE TUBES PRESENT IN THE AREA. SO FAR NO CASES OF ACTUAL CROSS CONTAMINATION HAVE BEEN IDENTIFIED.
SAMPLE RESIDUES HAVE BEEN FOUND AT THE EXIT OF THE WIDE BELT CARRIER BUFFER MODULES (WBB) WHERE THE SAMPLE TUBES PREVIOUSLY PARKED IN THE MODULE BUFFER RETURNED ON THE PIT LANE. THE WIDE BELT CARRIER BUFFER MODULE IS A SAMPLE CARRIERS COLLECTOR THAT PROVIDES THE CAPABILITY TO RELIEVE THE TRACK WORKLOAD. THE SAMPLE SPILLAGE MAY HAVE CAUSED THE CONTAMINATION OF OTHER UNCAPPED SAMPLE TUBES PRESENT IN THE AREA. SO FAR NO CASES OF ACTUAL CROSS CONTAMINATION HAVE BEEN IDENTIFIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1874426 | FLEXLAB | LABORATORY AUTOMATION SYSTEM | CEM | INPECO SA | FLX | 07640172340004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |