MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-08-04 for SYNCHRON CX3 DELTA 467501 manufactured by Beckman Coulter Inc..
[21424428]
A customer contacted beckman coulter inc (bec) to report an unknown fluid leak from inside the chemistry compartment on the synchron cx3 delta. A customer technical support advised the customer to notify their staff and stop using the system. No injury or exposure was reported.
Patient Sequence No: 1, Text Type: D, B5
[21516954]
A bec field service engineer replaced the drain line. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
Report Number | 2050012-2011-03890 |
MDR Report Key | 2192053 |
Report Source | 06 |
Date Received | 2011-08-04 |
Date of Report | 2011-07-05 |
Date of Event | 2011-07-05 |
Date Mfgr Received | 2011-07-05 |
Device Manufacturer Date | 2008-03-13 |
Date Added to Maude | 2011-11-02 |
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 | 2011-08-04 |
Model Number | CX3 DELTA |
Catalog Number | 467501 |
Lot Number | N/A |
ID Number | N/A |
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 | 2011-08-04 |