MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-05-17 for COULTER? LH SLIDEMAKER 6605633 manufactured by Beckman Coulter, Inc..
[2717544]
The customer reported approximately three (3) milliliters of red-pink fluid leaked inside the unit on the right side tray involving coulter lh slidemaker. The customer had on proper personal protective equipment (ppe) consisting of gloves, a laboratory coat, and eye protection during the incident. Patient results were not impacted. The customer has an exposure control management plan at the facility and cleaned up the fluid per laboratory protocol. The customer did not have direct contact with the fluid. There was no exposure to open lesions or mucus membranes. There was no report of injury or adverse effect associated with this incident. The field service engineer (fse) assessed the unit at the facility.
Patient Sequence No: 1, Text Type: D, B5
[9908344]
The field service engineer (fse) discovered diluent leaking from the pinch valves on the dispense module. The fse replaced the tubing on the dispense module to resolve the issue. The fse also noted getting basket move position errors. The fse ordered and replaced the sensors. The unit conformed to the manufacturer's published performance specifications. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2012-01656 |
| MDR Report Key | 2579240 |
| Report Source | 05,06 |
| Date Received | 2012-05-17 |
| Date of Report | 2012-04-27 |
| Date of Event | 2012-04-27 |
| Date Mfgr Received | 2012-04-27 |
| Device Manufacturer Date | 2007-03-01 |
| Date Added to Maude | 2012-09-24 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COULTER? LH SLIDEMAKER |
| Generic Name | SPINNER, SLIDE, AUTOMATED |
| Product Code | GKJ |
| Date Received | 2012-05-17 |
| Model Number | NA |
| 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 | 2012-05-17 |