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 2013-03-26 for COULTER? LH 750 SLIDEMAKER 6605633 manufactured by Beckman Coulter.
[3317608]
A customer contacted beckman coulter (bec) to report a leak of approximately 30 to 50 ml of diluted red fluid under the probe of a coulter lh 750 slidemaker. Per customer, they were getting "probe not down" errors. The operator was wearing personal protective equipment (ppe) consisting of a lab coat and gloves at the time of the event. No injury or exposure was reported. There was no impact to patient samples or results.
Patient Sequence No: 1, Text Type: D, B5
[10609503]
A field service engineer (fse) went on-site and confirmed the leak under the probe of the slidemaker and noted that the leak was coming from the rinse block being out of position. As a result the fluid from the probe was not draining and leaking into the drip tray in the bottom of the slidemaker. Fse cleaned up the leak and repositioned the rinse block which resolved the leak. Fse then confirmed the "probe not down" errors. Fse observed that the air cylinder for the dispense probe was not moving smoothly and replaced the air cylinder after which the dispense probe was moving freely. Fse also confirmed another leak under the transferring rod of the slidemaker which was coming from quick disconnect (qd) 8 that connects air/fluid lines from the slidemaker to the analytical station of the instrument. Fse replaced qd 8 which resolved the leak. The slidemaker was tested by making slides. No further leaks or errors were observed. The cause of the leak may be attributed to the misalignment of the probe rinse block, defective air cylinder and the qd 8 connector. The instrument alerted the customer of instrument issues. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2013-00471 |
| MDR Report Key | 3020387 |
| Report Source | 01,05,06 |
| Date Received | 2013-03-26 |
| Date of Report | 2013-02-26 |
| Date of Event | 2013-02-26 |
| Date Mfgr Received | 2013-02-26 |
| Device Manufacturer Date | 2004-06-01 |
| Date Added to Maude | 2013-05-24 |
| 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 |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COULTER? LH 750 SLIDEMAKER |
| Generic Name | AUTOMATED SLIDE SPINNER |
| Product Code | GKJ |
| Date Received | 2013-03-26 |
| Model Number | LH 750 SLIDEMAKER |
| Catalog Number | 6605633 |
| Lot Number | NA |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 250 S KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-03-26 |