MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-02-02 for SYNCHRON CX3 DELTA 467501 manufactured by Beckman Coulter, Inc..
[15414175]
On (b)(6) 2012, customer reported that the glucose 3 (glu3) and creatinine 3 (cre3) cups were overflowing on the cx3 delta instrument. No injuries were reported and no erroneous patient results were generated. Field service engineer (fse) examined the instrument and checked the drain tubing. Fse primed the instrument and the initial primes drained properly, but after a few primes the cups began overfilling. Fse also found holes in the c-arm pinch tubing. Fse replaced the peri-pump and pinch tubing. Repairs were verified per established procedures. This resolved the issue and no further leaks have been reported.
Patient Sequence No: 1, Text Type: D, B5
[15753126]
Beckman coulter identifier for this report is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-00367 |
| MDR Report Key | 2437365 |
| Report Source | 05,06 |
| Date Received | 2012-02-02 |
| Date of Report | 2012-01-11 |
| Date of Event | 2012-01-11 |
| Date Mfgr Received | 2012-01-11 |
| Device Manufacturer Date | 1995-05-04 |
| Date Added to Maude | 2012-08-10 |
| 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 | 2012-02-02 |
| Model Number | CX3 DELTA |
| Catalog Number | 467501 |
| ID Number | SOFTWARE VERSION 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 SOUTH KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-02-02 |