MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-02-27 for COULTER LH 750 ANALYZER 6605632 manufactured by Beckman Coulter, Inc..
[1932236]
A customer contacted beckman coulter inc. (bci) stating that the coulter lh 750 analyzer was leaking bloody fluid contained inside the unit. There was no death, injury, or affect to patient treatment. There was no contact with skin, eyes, mucous membranes, or open lesions as the leak was contained within the instrument. No medical treatment was sought by the operator.
Patient Sequence No: 1, Text Type: D, B5
[8835698]
A field service engineer (fse) was dispatched on (b)(4) 2011 for this event. The fse replaced the pinch valve (pv) which was cracked, all aspiration tubing to the rear blood detector, and the shear valve which was leaking. The fse also replaced the front blood detector and verified the instruments operation. The root cause is the hardware that was replaced during the subsequent instrument servicing for this event. 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-00104 |
| MDR Report Key | 2001977 |
| Report Source | 06 |
| Date Received | 2011-02-27 |
| Date of Report | 2011-01-26 |
| Date of Event | 2011-01-26 |
| Date Mfgr Received | 2011-01-26 |
| Device Manufacturer Date | 2006-06-01 |
| 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 | 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 | 2011-02-27 |
| 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 | 2011-02-27 |