MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-03-14 for COULTER LH 750 ANALYZER 6605632 manufactured by Beckman Coulter, Inc..
[1958935]
A customer contacted beckman coulter inc. (bci) reporting blood on the tube stopper, the stripper plate, and the needle assembly area of the coulter lh 750 analyzer. There was no blood exposure to mucous membranes (nose, eyes, and mouth) or open lesions. No one sought medical attention and patient treatment was not affected in this event.
Patient Sequence No: 1, Text Type: D, B5
[9097114]
It is possible that specimen leakage or clogging of the aspiration system can occur with excessive piercing of sample tubes, which causes significant coring of the stopper. A field service engineer (fse) was dispatched and cleaned the bellows assembly and the drain lines. Root cause is unknown at this time. 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 | 1061932-2011-00127 |
| MDR Report Key | 2016862 |
| Report Source | 06 |
| Date Received | 2011-03-14 |
| Date of Report | 2011-02-09 |
| Date of Event | 2011-02-09 |
| Date Mfgr Received | 2011-02-09 |
| Device Manufacturer Date | 2010-09-01 |
| Date Added to Maude | 2012-02-08 |
| 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 | RP |
| 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 | 2011-03-14 |
| 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 | 2011-03-14 |