MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2011-11-25 for OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER AU5431 6196000 manufactured by Beckman Coulter Mishima K.k..
[21979200]
The customer powered the unit off upon noticing the smoke. A bci field service engineer (fse) investigated the smoke and concluded that the cpu of (b)(4) pc to be defective. Fse installed new computer, cleaned cuvette, calibrated and qc tested the unit. Fse verified all repairs per established procedures and all results meet published performance specifications.
Patient Sequence No: 1, Text Type: N, H10
[22108642]
The customer contacted noticed a leak underneath the olympus au5400 clinical chemistry analyzer leaked during relocation of the instrument. The customer was wearing personal protective equipment (ppe) consisting of a lab coat, eye protection, and gloves. 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 result or treatment are associated with this event. A field service engineer (fse) was dispatched and noted the system was undergoing a location move and experienced a leak due to failed waste pump. A secondary pump also leaked, which may have been due to back pressure from the instrument, per product specialist. Drain terminals set up by plumber during instrument move are expelling air, which may have damaged the two waste pumps. Both the original and pump replaced from an inactive au5400 system (past warranty and questioned functional) caused leaks. The issue was resolved when replaced with a new waste pump. Fse replaced waste pump for the second time and ran the drain lines into a bucket to eliminate blockage as a cause for pump failure. The pump ran a full w1 without failure. Fse then re-attached drain lines to drain manifold in floor and ran another w1 without the pump backing up. It would seem that the initial pumps borrowed from the inactive instrument were faulty. All pumps were replaced. The fse verified repair per established procedures. Results meet published performance specifications. System validation documented in customer qc record.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050012-2010-08061 |
| MDR Report Key | 2348496 |
| Report Source | 01,06 |
| Date Received | 2011-11-25 |
| Date of Report | 2011-10-25 |
| Date of Event | 2011-10-24 |
| Date Mfgr Received | 2011-10-25 |
| Device Manufacturer Date | 2003-04-01 |
| Date Added to Maude | 2012-02-29 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS DUNG NGUYEN |
| Manufacturer Street | 250 S KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER MISHIMA K.K. |
| Manufacturer Street | 454-32 HIGASHINO, NAGAIZUMI-CH SUNTO-GUN |
| Manufacturer City | SCHIZUOKA, JP-NOTA 411-0931 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 411-0931 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER |
| Generic Name | BROMCRESOL GREEN DYE-BINDING, ALBUMIN |
| Product Code | CIX |
| Date Received | 2011-11-25 |
| Model Number | AU5431 |
| Catalog Number | 6196000 |
| Lot Number | N/A |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER MISHIMA K.K. |
| Manufacturer Address | 454-32 HIGASHINO, NAGAIZUMI-CH SUNTO-GUN SCHIZUOKA, JP-NOTA 411-0931 JA 411-0931 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-25 |