MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-05-09 for COULTER? LH 750 SLIDEMAKER 6605633 manufactured by Beckman Coulter, Inc..
[2811553]
A customer contacted beckman coulter inc. , (bec) and states there is a bloody leak in the drip tray of the coulter lh 750 slidemaker. The leak filled approximately 1/4 of the drip tray and was contained. The customer was wearing personal protective equipment (ppe) consisting of a lab coat, gloves, and eye protection. There was no exposure to mucous membranes or open wounds and medical attention was not sought. The material safety data sheet (msds) was not reviewed by the customer. It is unknown if there is an exposure/risk management plan available at the facility. There was no impact to patient results, as the unit does not generate results. There was no death, injury or an effect to patient treatment.
Patient Sequence No: 1, Text Type: D, B5
[9847157]
Per labeling, beckman coulter, inc. 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. The slidemaker may contain blood and diluent during normal operation, and cleaner during shutdown. A bec field service engineer (fse) was dispatched on (b)(4) 2012. The fse indicated that the customer reported labels not been placed on slides correctly and fluid detector errors. The fse inspected the instrument and found that probe was plugged. The fse flushed the probe and replaced pink stripe tubing. The fse also performed alignment verification on printer and verified instrument operation. The cause of the leak was the plugged probe. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2012-01480 |
| MDR Report Key | 2567397 |
| Report Source | 05,06 |
| Date Received | 2012-05-09 |
| Date of Report | 2012-04-17 |
| Date of Event | 2012-04-17 |
| Date Mfgr Received | 2012-04-17 |
| Device Manufacturer Date | 2007-10-01 |
| Date Added to Maude | 2012-09-19 |
| 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 CULTER 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 | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COULTER? LH 750 SLIDEMAKER |
| Generic Name | SPINNER, SLIDE, AUTOMATED |
| Product Code | GKJ |
| Date Received | 2012-05-09 |
| Catalog Number | 6605633 |
| Lot Number | N/A |
| ID 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 | 2012-05-09 |