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 2012-05-02 for COULTER? LH750 SLIDEMAKER 6605633 manufactured by Beckman Coulter, Inc..
[17409084]
A customer reported to beckman coulter inc (bec) that there was a fluid leak from coulter lh750 slidemaker. The drip tray was nearly full with approximately 10 ml of clear fluid, and the leak was contained within the instrument. The operator was wearing gloves and a lab coat when the leak was discovered. There was no report of exposure to mucous membranes or open wounds, and no one sought medical attention. The material safety data sheet was not reviewed, but an exposure control or risk management plan is in place. There was no impact to patient results. There was no report of death, injury or change to patient treatment associated with this event. The field service engineer (fse) found instrument was resetting itself due to electronic failures. The fse replaced the system control card and a bad power supply cable to resolve the issue. The repair was verified per the established procedures and the results met the published specifications. The leak may have contained blood, diluent, and cleaning agent. The cause of the leak was electronic failure due to faulty system control card and a bad power cable.
Patient Sequence No: 1, Text Type: D, B5
[17643742]
Result code: system control card (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2012-01355 |
| MDR Report Key | 2557481 |
| Report Source | 01,05,06 |
| Date Received | 2012-05-02 |
| Date of Report | 2012-04-07 |
| Date of Event | 2012-04-07 |
| Date Mfgr Received | 2012-04-07 |
| Device Manufacturer Date | 2004-01-01 |
| Date Added to Maude | 2012-09-18 |
| 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 | 11800 SW 147TH AVENUE |
| Manufacturer City | MIAMI FL 33196 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33196 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COULTER? LH750 SLIDEMAKER |
| Generic Name | SPINNER, SLIDE, AUTOMATED |
| Product Code | GKJ |
| Date Received | 2012-05-02 |
| Model Number | LH750 |
| Catalog Number | 6605633 |
| Lot Number | NA |
| 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 | 2012-05-02 |