MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-06-06 for COULTER LH 750 ANALYZER 6605632 manufactured by Beckman Coulter, Inc..
[2007245]
A customer contacted beckman coulter inc. (bci) stating that a leak was observed from the coulter lh 750 analyzer consisting of 250 milliliters of blood and clenz that was found underneath the right side of the diluter and on the counter. The customer was wearing personal protective equipment (ppe) consisting of a gown, gloves, and goggles and no one got splashed, sprayed or injured at the time of the incident. No injuries occurred and medical attention was not sought. There was no report of exposure to mucous membranes or open wounds. There was no death, injury or change to patient treatment attributed or connected to this event.
Patient Sequence No: 1, Text Type: D, B5
[9130434]
A field service engineer (fse) was dispatched and indicated that the rinse cup was not lifting up to the manual probe and backwash was not going into cup. The fse repaired the probe wipe and verified repair per established procedures. The root cause was attributed to the probe wipe lower rinse cup being loose and at an angle. As per product labeling, bci 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 | 1061932-2011-00559 |
| MDR Report Key | 2114204 |
| Report Source | 06 |
| Date Received | 2011-06-06 |
| Date of Report | 2011-05-05 |
| Date of Event | 2011-05-05 |
| Date Mfgr Received | 2011-05-05 |
| Device Manufacturer Date | 2003-06-01 |
| Date Added to Maude | 2012-04-16 |
| 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 |
| 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 | 2011-06-06 |
| 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 | 2011-06-06 |