MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-05-20 for COULTER? LH 750 SLIDEMAKER 6605645 manufactured by Beckman Coulter Inc..
[2006011]
A customer contacted beckman coulter stating that the coulter lh 750 slidestainer unit was running when it alerted the user for fluid in the tubing tray. There was some clear liquid (di water) observed in the bottom of the tubing tray. The user was wearing personal protective equipment (ppe) at the time of the event and was not exposed to any biohazard (only di water). There was no report of exposure to mucous membranes or open wounds. No injury was reported and medical attention was not sought.
Patient Sequence No: 1, Text Type: D, B5
[9077874]
Bci hotline performed troubleshooting over the phone and operator found a loose line. The customer reconnected the line and cleaned the tubing tray. However, when the bath drain was recycled, the line popped off again dripping di water on to tray. A field service engineer (fse) was dispatched on-site. Fse indicated the waste pump was unplugged and the replaced the plugged waste fitting. Fse verified repair per established procedures and results met published performance specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-00435 |
| MDR Report Key | 2098073 |
| Report Source | 06 |
| Date Received | 2011-05-20 |
| Date of Report | 2011-04-22 |
| Date of Event | 2011-04-22 |
| Date Mfgr Received | 2011-04-22 |
| Device Manufacturer Date | 2008-04-01 |
| Date Added to Maude | 2012-03-28 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. NORA ZEROUNIAN |
| Manufacturer Street | 250 S. KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| 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 | SLIDEMAKER |
| Product Code | KQC |
| Date Received | 2011-05-20 |
| Model Number | NA |
| Catalog Number | 6605645 |
| 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 | 11800 SW 147TH AVENUE, MIAMI FL 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-05-20 |