MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-05-11 for LH 750 SLIDEMAKER 6605633 manufactured by Beckman Coulter, Inc..
[2718779]
The customer indicated that a leak was present on a lh 750 slidemaker. The leak appeared to be diluent coming from tubing associated with the aspiration pump. The leak was not contained within the instrument and leaked onto the countertop. The customer cleaned up the leak. The volume of the leak was between five and ten milliliters. The healthcare worker interfacing with the machine was wearing personal protective equipment, which included a laboratory coat, glasses and gloves, at the time of occurrence. There was no exposure to healthcare worker uncovered wounds or mucous membranes and no injuries were reported. No personnel sought any medical attention in association with this event. Patient results were not affected by this event. No death, injury or modification to patient treatment was associated with this event. There was an exposure plan in place at the facility and the material safety data sheet was available for review.
Patient Sequence No: 1, Text Type: D, B5
[9849247]
Service was dispatched to the site on (b)(6) 2012 for this event. The field service engineer (fse) indicated that the leak occurred on the backwash tubing on the access module due to a hole in the tubing. The fse replaced the tubing. The slidemaker was returned into service after completion of verified repairs. The failure mode for this event is a hole in backwash tubing. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2012-01558 |
| MDR Report Key | 2571950 |
| Report Source | 05,06 |
| Date Received | 2012-05-11 |
| Date of Report | 2012-04-21 |
| Date of Event | 2012-04-21 |
| Date Mfgr Received | 2012-04-21 |
| Device Manufacturer Date | 2008-07-01 |
| Date Added to Maude | 2012-09-21 |
| 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 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 | 2012-05-11 |
| Model Number | NA |
| Catalog Number | 6605633 |
| Lot Number | NA |
| ID Number | NA |
| 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 | 2012-05-11 |