MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-04-17 for COULTER PREPPLUS2 378600 manufactured by Beckman Coulter, Inc..
[2591426]
Customer called to report observing fluid on the counter underneath the wash tower area of the coulter prepplus2. Customer was wearing personal protective equipment (ppe) consisting of a laboratory coat and gloves. Customer did not come in contact with the fluid, and medical attention was not sought. There was no report of exposure to mucous membranes or open wounds, and no one was splashed or sprayed. There was no death, injury or change to patient treatment attributed to or associated with this complaint. There was no impact to patient samples or results. The field service engineer (fse) inspected the instrument and found that a fitting was added to the wash station elbow to give the waste line more length. That fitting loosened from the tubing, which resulted in a leak. The fse removed the tubing and the fittings. The fse then installed new waste tubing, then reinstalled the fitting near the waste bottle. It is unknown who installed the fitting to extend the waste line. The fse then verified proper instrument performance to ensure that the services performed effectively resolved the instrument issue. Customer has not called back to report any further issues relating to this event. The root cause of the leak is attributed to a loose fitting at the wash station.
Patient Sequence No: 1, Text Type: D, B5
[9854295]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2012-01314 |
| MDR Report Key | 2537973 |
| Report Source | 05,06 |
| Date Received | 2012-04-17 |
| Date of Report | 2012-03-21 |
| Date of Event | 2012-03-21 |
| Date Mfgr Received | 2012-03-21 |
| Device Manufacturer Date | 2010-05-01 |
| Date Added to Maude | 2012-09-12 |
| 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. DUNG NGUYEN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 928216232 |
| Manufacturer Country | US |
| Manufacturer Postal | 928216232 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 11800 SW 147TH AVE. |
| Manufacturer City | MIAMI FL 33196 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33196 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COULTER PREPPLUS2 |
| Generic Name | STATION, PIPETTING AND DILUTING, FOR CLINICAL USE |
| Product Code | JQW |
| Date Received | 2012-04-17 |
| Model Number | NA |
| Catalog Number | 378600 |
| ID Number | SOFTWARE VERSION: 2.03 |
| 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 | 250 S. KRAEMER BLVD. BREA CA 92821623 US 92821 6232 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-17 |