MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2012-04-20 for UNICEL? DXH SLIDEMAKER STAINER N/A A82669 manufactured by Beckman Coulter Inc..
[22111078]
The customer reported that bath 1 of the unicel dxh slidemaker stainer had overflowed with methanol into the bath tray. The customer indicated that the bath tray filled completely and ultimately overflowed into the instrument. Approximately 10 ml was spilled into the instrument. The customer was wearing personal protective equipment consisting of gloves, lab coat and eye protection and no exposure or injury was reported. Patient results were not affected and there was no change to patient treatment in connection with this event. Beckman coulter field service engineer (fse) stated that the bath 1 sensor and overflow sensor were covered with debris causing the dxh slidemaker stainer to overflow. Fse proceeded to replace the bath 1 and overflow sensors and repair was verified per established procedures.
Patient Sequence No: 1, Text Type: D, B5
[22132030]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2012-01262 |
| MDR Report Key | 2544072 |
| Report Source | 01,05,06 |
| Date Received | 2012-04-20 |
| Date of Report | 2012-03-28 |
| Date of Event | 2012-03-28 |
| Date Mfgr Received | 2012-03-28 |
| Device Manufacturer Date | 2012-01-02 |
| Date Added to Maude | 2012-09-13 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 11800 SW 147TH AVENUE |
| 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 |
| Generic Name | SPINNER, SLIDE, AUTOMATED |
| Product Code | GKJ |
| Date Received | 2012-04-20 |
| Model Number | N/A |
| Catalog Number | A82669 |
| ID Number | SW VERSION 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 INC. |
| Manufacturer Address | 250 S. KRAEMER BLVD BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-20 |