MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-01-20 for SYNCHRON ? CX3 DELTA CLINICAL SYSTEM. 467501 manufactured by Beckman Coulter Inc..
[1727154]
A customer contacted beckman coulter inc. (bci) in regards to bun cup overfill and the synchron cx3 delta clinical system not calibrating. No injury was reported for this event.
Patient Sequence No: 1, Text Type: D, B5
[8972151]
Hotline assisted the customer to troubleshoot the instrument. The customer replaced the bun3 drain peri pump tubing. Hotline advised the customer to check the tubing to the c-cam and to clean the bottom coupler. No further calls been made in regards to this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-00186 |
| MDR Report Key | 1965941 |
| Report Source | 05 |
| Date Received | 2011-01-20 |
| Date of Report | 2010-12-21 |
| Date of Event | 2010-12-20 |
| Date Mfgr Received | 2010-12-21 |
| Device Manufacturer Date | 2006-05-25 |
| Date Added to Maude | 2012-01-24 |
| 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 | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. NORA ZEROUNIAN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613436 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON ? CX3 DELTA CLINICAL SYSTEM. |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJF |
| Date Received | 2011-01-20 |
| Model Number | CX3 DELTA |
| Catalog Number | 467501 |
| Lot Number | N/A |
| ID Number | N/A |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2011-01-20 |