MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-07-12 for SYNCHRON? CX3 DELTA CLINICAL SYSTEM 467501 manufactured by Beckman Coulter Inc..
[2136125]
A customer contacted beckman coulter inc. (bec) stating that the synchron cx3 delta clinical system was generating an excessive reference drift for all electrolytes. The customer also observed that the electrolyte injection cup (eic) was not filling. No injury or operator exposure was reported for this event.
Patient Sequence No: 1, Text Type: D, B5
[9198859]
Customer performed extensive troubleshooting at the direction of bec customer technical support (cts). Customer found the electrolyte reference damper was leaking onto the alkaline buffer solenoid valve. The customer also observed that the valve was corroded due to the leaking of electrolyte reference reagent. The cts suggested to the customer to replace the solenoid valve and fix the tubing from the electrolyte reference damper to prevent further leaking. The customer indicated that their biomedical department will replace the solenoid valve. Bec service was not dispatched for this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-02957 |
| MDR Report Key | 2159631 |
| Report Source | 06 |
| Date Received | 2011-07-12 |
| Date of Report | 2011-06-10 |
| Date of Event | 2011-06-10 |
| Date Mfgr Received | 2011-06-10 |
| Device Manufacturer Date | 1999-03-05 |
| Date Added to Maude | 2012-03-27 |
| 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 CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON? CX3 DELTA CLINICAL SYSTEM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJF |
| Date Received | 2011-07-12 |
| Model Number | CX3 DELTA |
| Catalog Number | 467501 |
| Lot Number | NA |
| ID Number | SV 4.7.05.01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER INC. |
| Manufacturer Address | 250 S KRAEMER BOULEVARD BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-07-12 |