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 2012-04-17 for COULTER? LH 750 SLIDEMAKER 6605633 manufactured by Beckman Coulter Inc..
[2607546]
A customer contacted beckman coulter inc. (bec) reporting that their coulter lh 750 slidemaker had a blood leak that was contained within the instrument. The operators were wearing personal protective equipment (ppe) consisting of gloves, gown and goggles at the time of the incident. No injury or exposure was reported. There was no impact to patient samples.
Patient Sequence No: 1, Text Type: D, B5
[9956203]
A field service engineer (fse) went on-site the day of the event and stated that no leak was present at the time of site visit, but cleaned up signs of old leak. Per fse, a technician had slides piled up under the dispense probe area that were pushed by the moving truck due to which rinse block (rb1) came out of the mounting brackets. The technician reinstalled rinse block rb1 which resolved the issue but did not clean up the spilled fluids below the rinse block. Another technician later discovered the fluids and initiated service call. The cause of the leak was the rinse block (rb1) that was pushed out of mounting brackets by a pile up of slides. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2012-01189 |
| MDR Report Key | 2538631 |
| Report Source | 01,05,06 |
| Date Received | 2012-04-17 |
| Date of Report | 2012-03-22 |
| Date of Event | 2012-03-22 |
| Date Mfgr Received | 2012-03-22 |
| Device Manufacturer Date | 2010-06-01 |
| Date Added to Maude | 2012-09-12 |
| 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 | 2012-04-17 |
| Model Number | LH 750 SLIDEMAKER |
| Catalog Number | 6605633 |
| Lot Number | NA |
| ID Number | SW 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 | 2012-04-17 |