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..
[2685934]
The customer reported that blood was leaking from the dispense probe and collecting in the catch tray on the lh750 slidemaker. The customer stated that the volume of the leak was approximately 21 ml and was contained within the instrument. The customer was wearing personal protective equipment consisting of a lab coat, gloves and goggles 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. The customer found the leak coming from the red stripe tubing through the pinch valve before the dispense probe (dp1). The customer stated that the tubing was pinched through causing blood to leak out of the pinch valve instead of passing through to dp1. The customer replaced the tubing and no further leak was observed.
Patient Sequence No: 1, Text Type: D, B5
[9822956]
Evaluation: method: evaluation was done by the customer. Conclusions: issue was resolved by the customer through troubleshooting. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2012-01423 |
| MDR Report Key | 2549967 |
| Report Source | 05,06 |
| Date Received | 2012-04-26 |
| Date of Report | 2012-04-04 |
| Date of Event | 2012-04-04 |
| Date Mfgr Received | 2012-04-04 |
| Device Manufacturer Date | 2008-07-01 |
| 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 | 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 | 2012-04-26 |