ARCHITECT C4000
Report
- Report Number
- 3016438761-2024-00003
- Event Type
- Malfunction
- Date Received
- January 2, 2024
- Date of Event
- December 13, 2023
- Report Date
- January 29, 2024
- Manufacturer
- ABBOTT LABORATORIES
- Product Code
- JJE
- UDI-DI
- 00380740003753
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
D10 - CONCOMITANT PRODUCT - UPDATED THIS SECTION TO ADD HCW PUMP OUT TO T FTG (ROHS), 7-205612-02, UNKNOWN. THE FSE CLEANED (UNBLOCKED) THE FITTING KIT, WASTE PUMP QUICK CONNECT (ROHS) AND HCW PUMP OUT TO T FTG (ROHS) ON THE ARCHITECT C4000, SERIAL NUMBER (B)(6), RESOLVING THE ISSUE. BOTH PARTS WERE DEEMED THE LIKELY CAUSE. THE ARCHITECT C4000, SERIAL NUMBER (B)(6) SERVICE HISTORY, REVEALED NO ADDITIONAL ISSUES OF SPLASHING FROM PARTS REPORTED ON THE (B)(6). A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE FITTING KIT, WASTE PUMP QUICK CONNECT OR THE HCW PUMP OUT TO T FTG (ROHS). NO TRENDS WERE IDENTIFIED FOR THE ARCHITECT C 4000, SERIAL NUMBER (B)(6) WITH REGARDS TO THE CURRENT ISSUE. A DEVICE HISTORY RECORD WAS REVIEWED AND DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS REGARDING THE CURRENT COMPLAINT FOR THE FITTING KIT, WASTE PUMP QUICK CONNECT (ROHS) OR THE HCW PUMP OUT TO T FTG (ROHS). LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED FOR ARCHITECT C4000, SERIAL NUMBER (B)(6), THE FITTING KIT, WASTE PUMP QUICK CONNECT (ROHS), OR HCW PUMP OUT TO T FTG (ROHS).
ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
THE CUSTOMER NOTICED A LEAK AT THE REAR OF THE ARCHITECT C4000 ANALYZER. THE CUSTOMER FOUND THE EXIT TUBING FOR THE HIGH CONCENTRATION (HC) WASTE PUMP HAD POPPED OFF. SHE PAUSED THE INSTRUMENT AND RECONNECTED THE TUBING AS IT WAS TRANSITIONING FROM RUNNING TO READY STATUS. SHE WAS WATCHING THE PUMP AS IT WAS STILL TRANSITIONING TO READY WHEN THE TUBING POPPED OFF AGAIN AND SPRAYED THE TECHNICIAN ON THE FACE AND HEAD WITH LIQUID WASTE FROM HIGH CONCENTRATION WASTE PUMP TUBING. THE CUSTOMER WAS WEARING GLASSES AT THE TIME. SHE IS CURRENTLY FOLLOWING HER LABORATORY PROTOCOL FOR AN EXPOSURE. THIS INCLUDED HER GOING TO THE ER AFTER THE EVENT AND HAVING A DRUG SCREEN AND LAB WORK DONE. THERE WAS NO MEDICAL TREATMENT OR INTERVENTION REPORTED. THERE WAS NO HARM TO THE CUSTOMER. THERE WAS NO IMPACT TO PATIENT MANAGEMENT OR USER SAFETY REPORTED.
THE CUSTOMER NOTICED A LEAK AT THE REAR OF THE ARCHITECT C4000 ANALYZER. THE CUSTOMER FOUND THE EXIT TUBING FOR THE HIGH CONCENTRATION (HC) WASTE PUMP HAD POPPED OFF. SHE PAUSED THE INSTRUMENT AND RECONNECTED THE TUBING AS IT WAS TRANSITIONING FROM RUNNING TO READY STATUS. SHE WAS WATCHING THE PUMP AS IT WAS STILL TRANSITIONING TO READY WHEN THE TUBING POPPED OFF AGAIN AND SPRAYED THE TECHNICIAN ON THE FACE AND HEAD WITH LIQUID WASTE FROM HIGH CONCENTRATION WASTE PUMP TUBING. THE CUSTOMER WAS WEARING GLASSES AT THE TIME. SHE IS CURRENTLY FOLLOWING HER LABORATORY PROTOCOL FOR AN EXPOSURE. THIS INCLUDED HER GOING TO THE ER AFTER THE EVENT AND HAVING A DRUG SCREEN AND LAB WORK DONE. THERE WAS NO MEDICAL TREATMENT OR INTERVENTION REPORTED. THERE WAS NO HARM TO THE CUSTOMER. THERE WAS NO IMPACT TO PATIENT MANAGEMENT OR USER SAFETY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1203909 | ARCHITECT C4000 | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | JJE | ABBOTT LABORATORIES | 00380740003753 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | FITTING KIT, WASTE PUMP QUICK CONNECT (ROHS), 7-20| FITTING KIT, WASTE PUMP QUICK CONNECT (ROHS), 7-20| HCW PUMP OUT TO T FTG (ROHS), 7-205612-02, UNKNOWN |