MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-03-18 for UNICEL? DXH SLIDEMAKER STAINER COULTER? CELLULAR ANALYSIS SYSTEM 775222 manufactured by Beckman Coulter.
[3383327]
A customer reported to beckman coulter (bec) that the unicel dxh slidemaker stainer coulter cellular analysis system leaked approximately 3 ml of clear fluid during shutdown. The leak was not contained within the instrument. The operator was wearing gloves and a lab coat at the time of the event. There was no injury or exposure to open wounds or mucous membranes, and the operator did not seek medical attention. Msds was not reviewed, but the facility has an exposure control plan. No erroneous results were generated.
Patient Sequence No: 1, Text Type: D, B5
[10632743]
Bec field service engineer (fse) observed that the source of the leak was the wash collar which needed alignment. The fse performed the wash collar alignment followed by daily checks as well as shutdowns. No further evidence of leaking was observed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2013-00342 |
| MDR Report Key | 3008064 |
| Report Source | 05,06 |
| Date Received | 2013-03-18 |
| Date of Report | 2013-02-17 |
| Date of Event | 2013-02-17 |
| Date Mfgr Received | 2013-02-17 |
| Device Manufacturer Date | 2012-02-01 |
| Date Added to Maude | 2013-05-20 |
| 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 |
| Manufacturer Street | 11800 SW 147TH AVE. |
| Manufacturer City | MIAMI FL 33196 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33196 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL? DXH SLIDEMAKER STAINER COULTER? CELLULAR ANALYSIS SYSTEM |
| Generic Name | SPINNER, SLIDE, AUTOMATED |
| Product Code | GKJ |
| Date Received | 2013-03-18 |
| Catalog Number | 775222 |
| Lot Number | NA |
| ID Number | SOFTWARE V. 1.5.1.0 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-03-18 |