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 2012-06-11 for COULTER? LH 750 SLIDEMAKER 6605633 manufactured by Beckman Coulter Inc..
[2672650]
A customer contacted beckman coulter inc. (bec) stating that clear liquid was leaking from the tubing connecting the coulter lh 750 hematology analyzer to their coulter lh 750 slidemaker. A few drops (approximately 0. 05 cc of the fluid was on the counter between the instruments. In addition, a few drops approximately 0. 2 cc) was observed under the laser. The slidemaker stopped making slides during leak and the leak ceased when the operator disabled the software connection to the slidemaker. There is an exposure control plan in place at the facility. The operator was wearing personal protective equipment (ppe) consisting of gloves and a lab coat. No injury or exposure was reported. There was no impact to patient samples or results.
Patient Sequence No: 1, Text Type: D, B5
[9903679]
A field service engineer (fse) went on-site the day of the event and found a hole in the tubing through pinch valve vl1 on the slidemaker sample access module (sam), which is housed under the cover of the lh 750 analytic station. Fse replaced the tubing which resolved the leak. During this service, fse inadvertently touched the tubing through the adjacent pinch valve vl2 and the line popped off. Just after the fse left, the customer reported the subsequent leak; the fse was paged and returned the same day to repair the leak. The cause of the leak was a hole in tubing and the subsequent leak was caused because tubing popped off due to fse error. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2012-01759 |
| MDR Report Key | 2609627 |
| Report Source | 01,05,06 |
| Date Received | 2012-06-11 |
| Date of Report | 2012-05-14 |
| Date of Event | 2012-05-14 |
| Date Mfgr Received | 2012-05-14 |
| Device Manufacturer Date | 2001-11-01 |
| Date Added to Maude | 2012-10-09 |
| 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 |
| 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 | 2012-06-11 |
| Model Number | LH 750 SLIDEMAKER |
| Catalog Number | 6605633 |
| Lot Number | NA |
| ID Number | SW VERSION 2D2 |
| 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 | 2012-06-11 |