MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-04-29 for UNICEL? DXH 800 COULTER? CELLULAR ANALYSIS SYSTEM 629029 manufactured by Beckman Coulter, Inc..
[2686962]
(b)(4)
Patient Sequence No: 1, Text Type: D, B5
[2749484]
The customer reported yellow striped tubing came off at (quick disconnect) qd421 on the unicel dxh 800 coulter cellular analysis system and bloody fluid leaked (3-4 ml) below the barcode reader and around the amtc (air mix temperature control) module. The yellow striped tubing is the drain line that attaches to the rinse block that cleans the probe. This line goes from the rinse block to qd421 and came loose where it attaches to qd421. The fluids that may be associated with this incident are blood, controls and diluent during normal operation; cleaner during shutdown. 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 (b)(4), 2012 the field service engineer called customer and confirmed that customer was able to put tubing back on. The customer requested service as a follow-up to verify the troubleshooting performed. On (b)(4) 2012, the fse visited the customer and confirmed the customer had run controls and had been running patients all day. No further issues were identified.
Patient Sequence No: 1, Text Type: D, B5
[9817570]
The cause for the leak was yellow striped tubing coming off at (quick disconnect) qd421. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[9962048]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2012-01401 |
| MDR Report Key | 2552393 |
| Report Source | 05,06 |
| Date Received | 2012-04-29 |
| Date of Report | 2012-04-04 |
| Date of Event | 2012-04-04 |
| Date Mfgr Received | 2012-04-04 |
| Device Manufacturer Date | 2012-02-01 |
| Date Added to Maude | 2012-09-17 |
| 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 |
| Previous Use Code | 3 |
| 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 | N |
| 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 |