MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-03-17 for COULTER? PREPPLUS 2 CYTOMETRY 378600 manufactured by Beckman Coulter, Inc..
[18079039]
Per the customer, the instrument is currently operational and did not show any error messages. A field service engineer (fse) was dispatched for this event and replaced the probe. The fse checked alignment and ran a self-test check on the instrument. 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
[18374898]
A customer contacted beckman coulter inc. (bci) stating that the coulter prepplus 2 cytometry instrument's probe crashed and bent resulting in blood dispensing throughout the back of the instrument. The tubing that holds onto the probe became disconnected and kept dispensing sheath fluid. The customer cleaned the instrument with bleach solution. There was no death or injury to the operator as a result of this incident. There was no exposure to open wounds or mucous membranes and operator did not seek medical attention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1061932-2011-00143 |
| MDR Report Key | 2021269 |
| Report Source | 05,06 |
| Date Received | 2011-03-17 |
| Date of Report | 2011-02-14 |
| Date of Event | 2011-02-14 |
| Date Mfgr Received | 2011-02-14 |
| Device Manufacturer Date | 2010-04-01 |
| Date Added to Maude | 2012-02-15 |
| 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 | 3 |
| 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? PREPPLUS 2 CYTOMETRY |
| Generic Name | COULTER? PREPPLUS 2 |
| Product Code | LOQ |
| Date Received | 2011-03-17 |
| Model Number | PREPPLUS 2 |
| Catalog Number | 378600 |
| Lot Number | NA |
| 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 | 2011-03-17 |