MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-02-03 for SYNCHRON CX3 DELTA CLINICAL SYSTEM 467501 manufactured by Beckman Coulter, Inc..
[2514075]
Customer called to report a leak from the electrolyte injection cup (eic) of the synchron cx3 delta clinical system. Customer performed instrument troubleshooting prior to calling the beckman coulter, inc hotline. The customer technical specialist (cts) instructed customer to massage the eic drain tubing and to correct the order of the tubing to the eic. The cts also instructed customer to flush the lines with bleach, which appeared to have resolved the issue. Customer was wearing personal protective equipment (ppe) consisting of a laboratory coat and gloves. Customer did not come in contact with the fluid, and medical attention was not sought. There was no report of exposure to mucous membranes or open wounds, and no one was splashed or sprayed. There was no death, injury or change to patient treatment attributed to or associated with this complaint. There was no impact to patient samples or results.
Patient Sequence No: 1, Text Type: D, B5
[9619859]
The root cause of the instrument issue appears to be due to a clot in the line, as the issue was resolved after flushing the lines with bleach. Onsite service was not initiated as these troubleshooting steps by telephone resolved the instrument issue. The instrument has been running within established specifications since the troubleshooting. ((b)(4). )
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-00384 |
| MDR Report Key | 2438841 |
| Report Source | 05,06 |
| Date Received | 2012-02-03 |
| Date of Report | 2012-01-04 |
| Date of Event | 2012-01-04 |
| Date Mfgr Received | 2012-01-04 |
| Device Manufacturer Date | 2003-09-30 |
| Date Added to Maude | 2012-08-13 |
| 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 | 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 928216232 |
| Manufacturer Country | US |
| Manufacturer Postal | 928216232 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821623 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 6232 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON CX3 DELTA CLINICAL SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY, MICRO, FOR CLINICAL USE |
| Product Code | JJF |
| Date Received | 2012-02-03 |
| Model Number | CX3 DELTA |
| Catalog Number | 467501 |
| ID Number | SW VERSION 4.0 |
| 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 92821623 US 92821 6232 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-02-03 |