MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-05-08 for SYNCHRON? CX3 TOTAL PROTEIN 467501 manufactured by Beckman Coulter, Inc..
[2654335]
The customer reported approximately 100 milliliters (ml) of clear yellow fluid leaked from the unit during priming involving synchron cx3 total protein. The customer noted the issue started during electrolyte cam maintenance. Beckman coulter customer technical support (cts) advised the customer to use proper personal protective equipment (ppe) prior to troubleshooting: gloves, laboratory coat, and eye protection during troubleshooting. The customer did not find any loose or disconnected line and noted the reagent tray had fluid. Erroneous results were not generated nor reported. The customer has an exposure control/risk management plan at the facility. The customer did not have direct contact with the fluid. There was no exposure to open lesions or mucus membranes. There was no report of injury or adverse effect associated with this incident. The field service engineer (fse) assessed the unit at the facility.
Patient Sequence No: 1, Text Type: D, B5
[9848137]
The field service engineer (fse) discovered eic cup overflowed caused by pinched tubing. The fse cleared the tubing and resolved the issue. The unit conformed to the manufacturer's published performance specifications. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-01120 |
| MDR Report Key | 2565326 |
| Report Source | 05,06 |
| Date Received | 2012-05-08 |
| Date of Report | 2012-04-20 |
| Date of Event | 2012-04-20 |
| Date Mfgr Received | 2012-04-20 |
| Device Manufacturer Date | 2006-03-16 |
| Date Added to Maude | 2012-09-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. DUNG NGUYEN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON? CX3 TOTAL PROTEIN |
| Generic Name | BIURET (COLORIMETRIC), TOTAL PROTEIN |
| Product Code | CEK |
| Date Received | 2012-05-08 |
| Model Number | NA |
| Catalog Number | 467501 |
| Lot Number | NA |
| ID Number | 6.1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-05-08 |