MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-05-29 for LH 750 SLIDEMAKER 6605633 manufactured by Beckman Coulter, Inc..
[19998294]
The customer reported that approximately twenty milliliters of an unknown blue-green liquid had leaked from under the trays of a lh 750 slidemaker. The leak was not contained to the instrument and had spilled on the counter. The healthcare worker interfacing with the machine was wearing personal protective equipment which included a laboratory coat and gloves. There was no exposure to healthcare worker uncovered wounds or mucous membranes and no injury was reported. No personnel sought any medical attention in association with this event. The instrument stopped making slides upon onset of leak. No patient results were affected by this event. No death or injury was associated with this event. There was an exposure plan in place at the facility and the material safety data sheet was reviewed.
Patient Sequence No: 1, Text Type: D, B5
[20274901]
Service was dispatched to the site for this event. The field service engineer (fse) found a leak in the tubing at valve vl20. He replaced the tubing to resolve the problem. Upon completion of the necessary and verified repairs, the instrument was returned back into service. The failure mode was a leak in the tubing at the vl20 valve. Upon recur, this failure mode would not have the potential to cause discrepant results. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2012-01694 |
| MDR Report Key | 2591117 |
| Report Source | 05,06 |
| Date Received | 2012-05-29 |
| Date of Report | 2012-05-07 |
| Date of Event | 2012-05-07 |
| Date Mfgr Received | 2012-05-07 |
| Device Manufacturer Date | 2003-12-01 |
| Date Added to Maude | 2012-10-01 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 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 | LH 750 SLIDEMAKER |
| Generic Name | SPINNER, SLIDE, AUTOMATED |
| Product Code | GKJ |
| Date Received | 2012-05-29 |
| Model Number | NA |
| Catalog Number | 6605633 |
| Lot Number | NA |
| ID Number | SOFTWARE VERSION 2D1 |
| 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 | 2012-05-29 |