MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-05-03 for UNICEL? DXH 800 COULTER? CELLULAR ANALYSIS SYSTEM 629029 manufactured by Beckman Coulter, Inc..
[2748218]
The customer reported a leak of approximately 4 ml of bloody fluid that was contained in the air mix temperature control (amtc) module overflow tray on the unicel dxh 800 coulter cellular analysis system. The leak was contained within the instrument. The customer stated the puddle was 6 inches long, however, he was unable to determine the quantity. The operator was wearing personal protective equipment (ppe) consisting of gloves, eye protection, 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, however, the facility does have an exposure control / risk management plan in place. On the day of the event, a field service engineer (fse) found debris lodged in the nrbc mix chamber. The debris was rubber from the specimen tube stopper. The debris prevented the chamber from draining, which caused it to overflow into overflow tray underneath the amtc module. The fse removed the debris from the chamber to correct the issue. Blood, 6c cell control, diluent, and dxh cell lyse may be present in the nrbc mix chamber during normal operation, and dxh cleaner during shutdown.
Patient Sequence No: 1, Text Type: D, B5
[9805913]
(b)(4). The leak was contained within the instrument. The customer stated the puddle was 6 inches long however, he was unable to determine the quantity.
Patient Sequence No: 1, Text Type: N, H10
[9837302]
The cause of the leak was a plugged nrbc mix chamber. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2012-01405 |
| MDR Report Key | 2559254 |
| Report Source | 05,06 |
| Date Received | 2012-05-03 |
| Date of Report | 2012-04-09 |
| Date of Event | 2012-04-09 |
| Date Mfgr Received | 2012-04-09 |
| Device Manufacturer Date | 2011-06-01 |
| Date Added to Maude | 2012-09-19 |
| 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 | 2012-05-03 |
| 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 | 2012-05-03 |