MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-08-16 for SYNCHRON CX3 DELTA 467501 manufactured by Beckman Coulter Inc..
[16571393]
On (b)(4) 2011, field service engineer (fse) visited and found an evidence of some form of overflowing; however the issue is no longer occurring. Per fse, cx3 overflow pan showed evidence of creatinine and wash fluid residue. Fse cleaned, secured all waste lines, tubing, and checked trap, cups pumps, and reagents for leaks. No further leaking observed. Primed the unit x80 with no leaks noted. Unable to reproduce issue despite running for close to 100 cycles. A definitive root cause is undetermined. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[16673594]
A customer contacted beckman coulter inc (bec) to report fluid leak underneath the synchron cx3 delta. The customer used personal protective equipment to clean the leak. No injury or exposure was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050012-2011-04569 |
| MDR Report Key | 2213580 |
| Report Source | 06 |
| Date Received | 2011-08-16 |
| Date of Report | 2011-07-17 |
| Date of Event | 2011-07-17 |
| Date Mfgr Received | 2011-07-17 |
| Device Manufacturer Date | 2006-05-23 |
| Date Added to Maude | 2012-05-09 |
| 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 BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER INC. |
| Manufacturer Street | 250 S KRAEMER BOULEVARD |
| 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 |
| Generic Name | MICRO CHEMISTRY ANALYZER FOR CLINICAL USE |
| Product Code | JJF |
| Date Received | 2011-08-16 |
| Model Number | CX3 DELTA |
| Catalog Number | 467501 |
| Lot Number | N/A |
| ID Number | SW 4.7 |
| 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 BOULEVARD BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-16 |