MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-11-21 for SYNCHRON CX3 DELTA CX 5 DELTA 467501 manufactured by Beckman Coulter, Inc..
[2352220]
On (b)(6) 2011, customer reported that there was a leak from the electrolyte injection cup and lines 57, 38, and 73 were "popping off" on the cx3 delta instrument. No injuries were reported and erroneous patient results were generated. Field service engineer (fse) examined the instrument and found the pinch valve at the bottom of the flow cell had stopped working, which caused line 73 to pop off and spill reagent. Fse replaced the pinch valve and cleaned the spill. Fse performed calibration and tested quality control, and it was good. Repairs were verified per established procedures.
Patient Sequence No: 1, Text Type: D, B5
[9485533]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-07694 |
| MDR Report Key | 2344389 |
| Report Source | 05,06 |
| Date Received | 2011-11-21 |
| Date of Report | 2011-10-26 |
| Date of Event | 2011-10-26 |
| Date Mfgr Received | 2011-10-26 |
| Device Manufacturer Date | 2005-06-28 |
| Date Added to Maude | 2012-07-17 |
| 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 SOUTH KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON CX3 DELTA |
| Generic Name | ANALYZER, CHEMISTRY, MICRO, FOR CLINICAL USE |
| Product Code | JJF |
| Date Received | 2011-11-21 |
| Model Number | CX 5 DELTA |
| Catalog Number | 467501 |
| 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 SOUTH KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-21 |