MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-09-13 for SYNCHRON? CX3 DELTA CLINICAL SYSTEM 467501 manufactured by Beckman Coulter Inc..
[17062035]
A customer contacted beckman coulter inc. (bci) regarding a leak inside the flow cell compartment area and shift in carbon dioxide (co2) qc results generated by the synchron cx3 delta clinical system. No erroneous results were reported outside the laboratory and no operator exposure during this hardware failure. The customer indicated that there was no affects on patient treatment because the issue was caught by observing the qc shift results.
Patient Sequence No: 1, Text Type: D, B5
[17283437]
A field service engineer (fse) visited and performed routine repairs. Fse discovered that the co2 acid port (line 57) was disconnected at the flow mixer. Reconnected the line, which resolved the leaking issue. Fse also replaced the co2 electrode and membrane and recalibrated co2. After repairs, qc met specifications and recovery was improved.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2010-00740 |
| MDR Report Key | 1832484 |
| Report Source | 05 |
| Date Received | 2010-09-13 |
| Date of Report | 2010-09-10 |
| Date of Event | 2010-08-24 |
| Date Mfgr Received | 2010-08-24 |
| Device Manufacturer Date | 1997-05-22 |
| Date Added to Maude | 2010-11-19 |
| 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 |
| 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 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 | OT |
| 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 | 2010-09-13 |
| Model Number | CX3 DELTA |
| Catalog Number | 467501 |
| Lot Number | NA |
| 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 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-09-13 |