MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-05-12 for COULTER LH 750 ANALYZER 6605632 manufactured by Beckman Coulter, Inc..
[17723169]
A customer contacted beckman coulter inc (bci) stating that there was a mixture of blood and clenz in the drip tray underneath the blood sampling valve (bsv) of the coulter lh 750 analyzer. The customer was wearing personal protective equipment. There was no exposure, or contact with eyes or skin, open wounds or mucous membrane. There was no effect to patients or end users.
Patient Sequence No: 1, Text Type: D, B5
[17923015]
A field service engineer (fse) was dispatched on (b)(4) 2011 for this event. The fse found the tubing on the top of the vacuum chamber crimpled under the blood detector bracket. The fse corrected the tubing routing. The fse also found the incorrect fitting on the quick disconnect for the rinse cup drain. Per the fse, the fitting was too small allowing a break in vacuum, thus the fse replaced it with the correct fitting. The fse also replaced the leaking pneumatic tubing on the blood sampling valve (bsv) left pad actuator. The root cause of the leak is the blood sampling valve (bsv) not being in the correct position to deliver the blood due to the leak on the pneumatic tubing on the left cylinder. As per product 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-00404 |
| MDR Report Key | 2087776 |
| Report Source | 06 |
| Date Received | 2011-05-12 |
| Date of Report | 2011-04-12 |
| Date of Event | 2011-04-12 |
| Date Mfgr Received | 2011-04-12 |
| Device Manufacturer Date | 2009-01-01 |
| 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 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COULTER LH 750 ANALYZER |
| Generic Name | AUTOMATED DIFFERENTIAL CELL COUNTER |
| Product Code | LOQ |
| Date Received | 2011-05-12 |
| Model Number | LH 750 |
| Catalog Number | 6605632 |
| Lot 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 | 11800 SW 147TH AVENUE MIAMI FL 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-05-12 |