MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2012-04-25 for COULTER? LH 750 SLIDEMAKER LH750 6605633 manufactured by Beckman Coulter, Inc..
[18058339]
A customer reported to beckman coulter, inc. (bec) that approximately 20 ml fluid leaked out from coulter lh 750 slidemaker. The customer clamped off the tubing to stop the leak and powered off the instrument. The customer was wearing personal protective equipment including gloves and goggles at the time of the event. There was no report of exposure to mucous membrane or open wounds. No one sought medical attention. Msds was reviewed, and the facility has an exposure control or risk management plan in place. There was no impact to patient results, and no death, injury or change to patient treatment as a result of this incident. The field service engineer (fse) found the hivac pneumatic isolation valve vl-2 stuck not allowing the vacuum accumulator to properly drain; it overfilled and the fluid was pulled into the compressor and leaked out the compressors exhaust port. The waste check valve and vl-2 were replaced to resolve the issue. Vl-2 is the hivac pneumatic isolation valve applies either 5 psi pressure or high vacuum to the vacuum accumulator tk3 (tank3) in the slide maker connected to the lh750 instrument. Tk3 contains blood, diluent or cleaning reagent. The cause of the leak was faulty hivac pneumatic isolation valve vl-2.
Patient Sequence No: 1, Text Type: D, B5
[18520649]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2012-01256 |
| MDR Report Key | 2548649 |
| Report Source | 01,05,06 |
| Date Received | 2012-04-25 |
| Date of Report | 2012-03-28 |
| Date of Event | 2012-03-28 |
| Date Mfgr Received | 2012-03-28 |
| Device Manufacturer Date | 2007-07-01 |
| Date Added to Maude | 2012-09-13 |
| 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 AVE. |
| Manufacturer City | MIAMI FL 33196 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33196 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COULTER? LH 750 SLIDEMAKER |
| Generic Name | SPINNER, SLIDE, AUTOMATED |
| Product Code | GKJ |
| Date Received | 2012-04-25 |
| Model Number | LH750 |
| Catalog Number | 6605633 |
| Lot Number | NA |
| ID Number | SOFTWARE V. 1A |
| 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 | 2012-04-25 |