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 750 SLIDEMAKER 6605633 manufactured by Beckman Coulter Inc..
[16751239]
A customer contacted beckman coulter inc (bec) stating that they noticed a diluted red color leak that came from the back right side of their coulter lh 750 slidemaker. There is an exposure control plan in place at the facility. The operators were wearing personal protective equipment (ppe) consisting of gloves and a lab coat at the time of the incident. No injury or exposure was reported. There was no impact to patient samples.
Patient Sequence No: 1, Text Type: D, B5
[17043599]
A field service engineer (fse) went on-site and replaced the tubing through valve vl20 after noting that it had a hole in it (vl20 provides pressurized diluent to rinse the reservoir and dispense lines and tubing may contain diluent or cleaner). The issue was resolved. The cause of the leak is a hole in the tubing through vl20. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2012-01671 |
| MDR Report Key | 2579263 |
| Report Source | 05,06 |
| Date Received | 2012-05-17 |
| Date of Report | 2012-05-01 |
| Date of Event | 2012-05-01 |
| Date Mfgr Received | 2012-05-01 |
| Device Manufacturer Date | 2003-07-01 |
| 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 |
| 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? LH 750 SLIDEMAKER |
| Generic Name | AUTOMATED SLIDE SPINNER |
| Product Code | GKJ |
| Date Received | 2012-05-17 |
| Model Number | LH 750 SLIDEMAKER |
| Catalog Number | 6605633 |
| Lot Number | NA |
| ID Number | NI |
| 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 |