MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2012-04-29 for UNICEL? DXH 800 COULTER? CELLULAR ANALYSIS SYSTEM 629029 manufactured by Beckman Coulter, Inc..
[2686484]
The customer reported liquid leak of about a 3-4 cc reddish diluent leak near the front right side of unicel dxh 800 coulter cellular analysis system. The leak was not contained within the instrument.
Patient Sequence No: 1, Text Type: D, B5
[2686960]
The operator was wearing personal protective equipment (ppe) consisting of gloves and lab coat at the time of the incident. Patient samples or results were not reported to have been affected by the leak. No injuries occurred and medical attention was not sought. The customer did not report exposure (splashed or sprayed) to mucous membranes or open wounds. The customer did not review the msds. The facility does have an exposure control / risk management plan in place. The customer stated that patient results were erratic, however the results were not reported outside the lab. Customer had no printouts of erratic results. On the day of the event ((b)(6) 2012) a field service engineer (fse) was dispatched to investigate the event. The fse found the nrbc mixing chamber overflowing and leaking liquid on the cassette track. The fse cleaned and bleached the nrbc mixing chamber and performed the nrbc mixing chamber drain function ten times to verify instrument operations. The fse stated the nrbc mixing chamber was plugged; although the fse was able to flush the tubing, he was unable to determine the material that caused the plug.
Patient Sequence No: 1, Text Type: D, B5
[2749972]
(b)(4)
Patient Sequence No: 1, Text Type: D, B5
[9968428]
(b)(4). Patient samples or results were not reported to have been affected by the leak.
Patient Sequence No: 1, Text Type: N, H10
[9968429]
The customer reported liquid leak of about a 3-4 cc reddish diluent leak near the front right side of unicel dxh 800 coulter cellular analysis system. The leak was not contained within the instrument.
Patient Sequence No: 1, Text Type: N, H10
[9968431]
The cause for the overflow leak was a plug in the nrbc mixing chamber drain line. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2012-01296 |
| MDR Report Key | 2552383 |
| Report Source | 01,05,06 |
| Date Received | 2012-04-29 |
| Date of Report | 2012-04-03 |
| Date of Event | 2012-04-03 |
| Date Mfgr Received | 2012-04-03 |
| Device Manufacturer Date | 2011-06-01 |
| Date Added to Maude | 2012-09-14 |
| 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 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| 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 | NO |
| Previous Use Code | 3 |
| Removal Correction Number | 2050012-04/05/2012-006C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL? DXH 800 COULTER? CELLULAR ANALYSIS SYSTEM |
| Generic Name | SPINNER, SLIDE, AUTOMATED |
| Product Code | GKJ |
| Date Received | 2012-04-29 |
| Model Number | DXH 800 |
| Catalog Number | 629029 |
| Lot Number | N/A |
| ID Number | SW 1.1.3.1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-29 |