MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-05-10 for BECKMAN COULTER ? COULTER ? LH 750 SLIDEMAKER LH750 SM 6605633 manufactured by Beckman Coulter, Inc..
[2651996]
The customer that while they received fluid detector 7 errors from the beckman coulter lh 750 slidemaker a 5 ml green fluid leaked from under the instrument and onto the counter. The customer was wearing personal protective equipment (ppe) consisting of a lab coat and gloves. The customer did not come in contact with the fluid and did not seek medical attention. No exposure (sprayed or splashed) to mucous membranes or open wounds were reported. No death, injury or changes to patient treatment or results are associated with this event. The customer did not review the msds; however, the facility does have a risk management / exposure control plan is in place. On the day of the event, a field service engineer (fse) was dispatched to investigate the event. The fse found a problem with the sample access module and replaced the access reservoir. The fse ran numerous samples and no errors were noted. The service activity performed was verified to meet the specified requirements per established procedures. Results meet published performance specifications. System validation documented in customer qc record. The sample access module carries blood, diluent and clenz reagents.
Patient Sequence No: 1, Text Type: D, B5
[9851080]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2012-01483 |
| MDR Report Key | 2568718 |
| Report Source | 05,06 |
| Date Received | 2012-05-10 |
| Date of Report | 2012-04-15 |
| Date of Event | 2012-04-15 |
| Date Mfgr Received | 2012-04-15 |
| Device Manufacturer Date | 2009-03-01 |
| Date Added to Maude | 2012-09-20 |
| 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 | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BECKMAN COULTER ? COULTER ? LH 750 SLIDEMAKER |
| Generic Name | SPINNER, SLIDE, AUTOMATED |
| Product Code | GKJ |
| Date Received | 2012-05-10 |
| Model Number | LH750 SM |
| Catalog Number | 6605633 |
| Lot Number | N/A |
| ID 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 | 250 S KRAEMER BLVD BREA, CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-05-10 |