MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-04-26 for LH750 SLIDEMAKER N/A 6605633 manufactured by Beckman Coulter Inc..
[2747497]
The customer reported a large volume of fluid leak from the sample access module (sam) of the lh750 slidemaker. The customer stated that the fluid consisted of diluent mixed with blood and had leaked onto the counter top. The customer was wearing personal protective equipment consisting of gloves and a lab coat at the time of the event and no exposure or injury was reported. Patient results were not affected and there was no change to patient treatment in connection with this event. Beckman coulter field service engineer (fse) stated that the leak appeared to be coming from the duro tubing at the fitting to solenoid 118 where it likely became loose over time. The fse replaced the sample access module and repair was verified per established procedures. Root cause of the leak was due to a loose tubing at fitting.
Patient Sequence No: 1, Text Type: D, B5
[9822021]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2012-01419 |
| MDR Report Key | 2549952 |
| Report Source | 05,06 |
| Date Received | 2012-04-26 |
| Date of Report | 2012-04-03 |
| Date of Event | 2012-04-03 |
| Date Mfgr Received | 2012-04-03 |
| Device Manufacturer Date | 2007-12-01 |
| 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 BOULEVARD |
| 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 | LH750 SLIDEMAKER |
| Generic Name | SPINNER, SLIDE, AUTOMATED |
| Product Code | GKJ |
| Date Received | 2012-04-26 |
| Model Number | N/A |
| Catalog Number | 6605633 |
| 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 | 2012-04-26 |