MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-11-16 for IMMAGE? IMMUNOCHEMISTRY SYSTEM 47000 manufactured by Beckman Coulter, Inc..
[3042150]
The customer reported the reagent probe wash station overflowed and did not draining on the immage immunochemistry system. The leak was contained to the top of the instrument. The customer inspected the wash cup for obstructions; no obstructions were found. The customer wore personal protective equipment consisting of gloves, eye protection, and lab coat at the time of the incident. The customer did not come in contact with the fluid and did not seek medical attention. No exposure (sprayed or splashed) to mucous membranes or open wounds were reported. No death, injury or changes to patient treatment or results are attributed or associated with this event. The customer did not review the msds; however, the facility has an exposure control or risk management plan in place.
Patient Sequence No: 1, Text Type: D, B5
[10320589]
On (b)(4) 2012, a field service engineer (fse) was on site to investigate the incident. The fse removed the wash station and cleaned the wash cup. The fse then inspected the tubing and no obstruction was noted. The fse replaced the in-liner filter which resolved the leak. The failure mode of the event was a weak in-line filter failure (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-01844 |
| MDR Report Key | 2836626 |
| Report Source | 05,06 |
| Date Received | 2012-11-16 |
| Date of Report | 2012-10-23 |
| Date of Event | 2012-10-23 |
| Date Mfgr Received | 2012-10-23 |
| Device Manufacturer Date | 2003-05-23 |
| Date Added to Maude | 2013-02-25 |
| 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 | 250 S KRAEMER BLVD |
| Manufacturer City | BREA, CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMAGE? IMMUNOCHEMISTRY SYSTEM |
| Generic Name | NEPHELOMETER, FOR CLINICAL USE |
| Product Code | JQX |
| Date Received | 2012-11-16 |
| Catalog Number | 47000 |
| Lot Number | N/A |
| ID Number | SW 1.6 |
| 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 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-11-16 |