MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-03-10 for COULTER LH 750 SLIDE STAINER ANALYZER 6605645 manufactured by Beckman Coulter, Inc..
[1915449]
A customer contacted beckman coulter inc. (bci) reporting a leak in the lh 750 slide stainer analyzer due to a fluid that was observed over the catch tray. The leak was contained internally within the slide stainer and did not leak outside the instrument. No injuries occurred and medical attention was not sought. There was no report of exposure to mucous membranes or open wounds.
Patient Sequence No: 1, Text Type: D, B5
[9158210]
A field service engineer (fse) was dispatched for this event and confirmed that the leak was methanol. The leak was considered minimal and was cleaned up according to the defined laboratory protocol by the fse. The fse replaced the peristaltic pump and verified repair per established procedures. Results met published performance specifications. The root cause for the leak was associated with the peristaltic pump. Per product labeling, bci urges its customers to comply with all national health and safety standards such as the use of barrier protection. This may include, but it is not limited to, protective eyewear, gloves, and suitable laboratory attire when operating or maintaining this or any other automated laboratory analyzer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-00126 |
| MDR Report Key | 2015325 |
| Report Source | 06 |
| Date Received | 2011-03-10 |
| Date of Report | 2010-08-10 |
| Date of Event | 2010-08-09 |
| Date Mfgr Received | 2010-08-10 |
| Device Manufacturer Date | 2004-08-01 |
| Date Added to Maude | 2012-02-08 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS NORA ZEROUNIAN |
| Manufacturer Street | 250 S KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| 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 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COULTER LH 750 SLIDE STAINER ANALYZER |
| Generic Name | AUTOMATED DIFFERENTIAL CELL COUNTER |
| Product Code | LOQ |
| Date Received | 2011-03-10 |
| Model Number | LH 750 SLIDE STAINER |
| Catalog Number | 6605645 |
| Lot Number | N/A |
| 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 | 11800 SW 147TH AVENUE MIAMI FL 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-10 |