MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-08-01 for SYNCHON CX3 DELTA 467501 manufactured by Beckman Coulter, Inc..
[2732829]
The customer reported obtaining suppressed calcium results and sodium reference drift results generated on the synchon cx3 delta clinical system. The customer recalibrated the instrument and re-run qc which was within range. Post calibration, the customer noticed a teaspoon of clear fluid leaked out from calcium electrode channel. Per customer, no erroneous patient results were generated. Beckman coulter inc. Customer technical specialist (cts), reviewed material safety data sheet (msds) and chemical exposure plan in the laboratory and assisted the customer in troubleshooting the event. The cts directed the customer on replacing calcium electrode quadring. However, the issue persisted. Cts generated service call. The customer was wearing personal protective equipment (ppe) consisting of a lab coat and gloves. The customer did not come in contact with the fluid and did not seek medical attention. No exposure (sprayed or splashed) to mucous membranes or open wounds were reported. No death, injury or changes to patient treatment or results are associated with this event. On (b)(4) 2012, a field service engineer (fse) visited the site. The fse removed and replaced the following: calcium electrode assembly. Potassium and chloride electrode body. Retainer nut. Service activity performed was verified to meet the specified requirement per established procedures. Routine service call resolved the issue. The cause of the event was a hairline fracture in the retainer nut.
Patient Sequence No: 1, Text Type: D, B5
[10110590]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-01621 |
| MDR Report Key | 2678075 |
| Report Source | 05,06 |
| Date Received | 2012-08-01 |
| Date of Report | 2012-07-09 |
| Date of Event | 2012-07-09 |
| Date Mfgr Received | 2012-07-09 |
| Device Manufacturer Date | 1995-07-18 |
| Date Added to Maude | 2012-11-23 |
| 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 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 250 S KRAEMER BLVD |
| Manufacturer City | BREA, CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHON CX3 DELTA |
| Generic Name | ANALYZER, CHEMISTRY, MICRO, FOR CLINICAL USE |
| Product Code | JJF |
| Date Received | 2012-08-01 |
| Catalog Number | 467501 |
| Lot Number | N/A |
| ID Number | SW 7.0 |
| 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 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-01 |