MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-10-07 for UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM A27318 manufactured by Beckman Coulter, Inc..
[2209835]
Customer reported that fifty (50) erroneously sodium and calcium results were generated by the unicel dxc 600i synchron access system. The results were reported out of the laboratory. One patient was admitted to the hospital based upon an erroneously low calcium result. System calibration and quality controls were within specification prior to the event. The samples were retested and yielded results within expectation. Amended results were issued. The patient was released from the hospital the following day. It is not known if there were any changes to the patients' care or treatment. There are no reports of any treatment causing harm to this patient.
Patient Sequence No: 1, Text Type: D, B5
[9436285]
The field service engineer (fse) visited the facility and examined the system. Cultures of the system were not taken or provided. The fse found an unspecified white precipitate in the flow cell. The fse cleaned the flow cell and replaced the carbon bridge. Although several parts were replaced and this measure may have resolved the problem, a clear root cause could not be determined; accordingly no conclusion can be drawn. This reportable event was identified during a retrospective review of complaints conducted between (b)(6) 2008 and (b)(6) 2010 for additional reportable events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-06028 |
| MDR Report Key | 2288266 |
| Report Source | 05,06 |
| Date Received | 2011-10-07 |
| Date of Report | 2008-07-01 |
| Date of Event | 2008-06-25 |
| Date Mfgr Received | 2008-07-01 |
| Device Manufacturer Date | 2006-11-01 |
| Date Added to Maude | 2011-10-13 |
| 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 NORA ZEROUNIAN |
| Manufacturer Street | 250 S KRAEMER BLVD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | Z-0863-2010 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM |
| Product Code | JFP |
| Date Received | 2011-10-07 |
| Model Number | NA |
| Catalog Number | A27318 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 1. Hospitalization | 2011-10-07 |