MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-03-30 for SYNCHRON CX3 DELTA 467501 manufactured by Beckman Coulter Inc..
[19203155]
A customer contacted beckman coulter inc. , (bci) and stated that reagent was leaking into the reagent compartment on synchron cx3 delta instrument. Customer was unable to locate the source of leak. No injury was reported on this issue.
Patient Sequence No: 1, Text Type: D, B5
[19423549]
A customer technical service (cts) advised the customer to stop the system and not to use the system a field service engineer (fse) primed the analyzer, but did not see leakage from the tubing or components. The fse noted wash bottle appears to have slight leak at seam on top and ordered a new wash bottle for replacement. Root cause of this event is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-00911 |
| MDR Report Key | 2033002 |
| Report Source | 07 |
| Date Received | 2011-03-30 |
| Date of Report | 2011-02-28 |
| Date of Event | 2011-02-28 |
| Date Mfgr Received | 2011-02-28 |
| Device Manufacturer Date | 1999-05-03 |
| Date Added to Maude | 2012-02-02 |
| 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 |
| Health Professional | 0 |
| 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 | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER INC. |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON CX3 DELTA |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJF |
| Date Received | 2011-03-30 |
| Model Number | CX3 DELTA |
| Catalog Number | 467501 |
| 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 | 2011-03-30 |