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 2013-03-27 for COULTER? LH 750 SLIDEMAKER 6605633 manufactured by Beckman Coulter.
[3319597]
The affiliate reported the customer alleged fluid detector (fd) 6 errors and approximately five milliliters of clear fluid leaked within the instrument from the right side tray involving the coulter lh 750 slidemaker. The operator was wearing personal protective equipment (ppe) consisting of protective gloves and a laboratory coat and did not have direct contact with the fluid. There was no operator injury or adverse effect associated with this event. No erroneous patient results were generated. There was no patient impact. The laboratory has an exposure control/risk management plan in place. A beckman coulter field service engineer (fse) was dispatched to evaluate the instrument.
Patient Sequence No: 1, Text Type: D, B5
[10637229]
The field service engineer (fse) observed the probe rinse supply line was routed through pinch valve vl20 instead of pinch valve vl19. The fse rerouted the tubing through the correct pinch valve and resolved the fluid leak issue. The instrument conformed to the manufacturer's published specifications and was returned to normal operation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2013-00512 |
| MDR Report Key | 3024447 |
| Report Source | 01,05,06 |
| Date Received | 2013-03-27 |
| Date of Report | 2013-02-26 |
| Date of Event | 2013-02-26 |
| Date Mfgr Received | 2013-02-26 |
| Device Manufacturer Date | 2005-06-01 |
| Date Added to Maude | 2013-05-28 |
| 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 |
| 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 750 SLIDEMAKER |
| Generic Name | SPINNER, SLIDE, AUTOMATED |
| Product Code | GKJ |
| Date Received | 2013-03-27 |
| 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 |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-03-27 |