MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2011-04-13 for COULTER LH 750 ANALYZER 6605632 manufactured by Beckman Coulter Inc..
[18080027]
Bci field service engineer (fse) was dispatched on (b)(6) 2011. Fse replaced tubing sample line from mixing chamber to flowcell, and stabilyse line tubing. Performance of the analyzer was verified. 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 root cause for the leak was associated with a small hole on the tubing from mixing chamber to flowcell and a tear in the stabilyse line tubing.
Patient Sequence No: 1, Text Type: N, H10
[18177696]
A customer contacted beckman coulter inc. (bci) stating that a small leak with blood was found on the differential mixing chamber of the coulter lh750 hematology analyzer. This leak overflowed onto the counter. User was wearing personal protective equipment (ppe) consisting of lab coat, gloves and goggle at time of incident. No injuries occurred and medical attention was not sought. There was no report of exposure to mucous membranes or open wounds. The lab's exposure control/risk management plans are in place. No reports of death, injury, or change to patient treatment have been reported in connection with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1061932-2011-00256 |
| MDR Report Key | 2055081 |
| Report Source | 01,06 |
| Date Received | 2011-04-13 |
| Date of Report | 2011-03-14 |
| Date of Event | 2011-03-14 |
| Date Mfgr Received | 2011-03-14 |
| Device Manufacturer Date | 2006-01-01 |
| Date Added to Maude | 2012-02-16 |
| 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 | IN |
| 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 | 2011-04-13 |
| Model Number | LH 750 |
| Catalog Number | 6605632 |
| 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 | 11800 SW 147TH AVENUE MIAMI FL 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-13 |