MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-06-06 for COULTER LH SLIDEMAKER 6605633 manufactured by Beckman Coulter, Inc..
[2744994]
Customer reported to beckman coulter, inc. (bec) that there was a leak under the coulter lh 750 slidemaker. Customer reported that the leak was not contained within the instrument. Customer reported that the volume of the leak was 10-15 ml. Customer reported that patient results were not affected. There was no report of any adverse event or injury requiring medical intervention or patient treatment. Bec field service engineer (fse) found the input quick disconnect on the left side of the coulter lh 750 slidemaker, behind the fluidics module, was not tight enough to provide a proper seal. The fse replaced all of the tubing in the dispense module, cleaned the buildup, checked for damage to the quick disconnects and verified operation of the instrument.
Patient Sequence No: 1, Text Type: D, B5
[9824595]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2012-01839 |
| MDR Report Key | 2602005 |
| Report Source | 05,06 |
| Date Received | 2012-06-06 |
| Date of Report | 2012-05-12 |
| Date of Event | 2012-05-12 |
| Date Mfgr Received | 2012-05-12 |
| Device Manufacturer Date | 2003-06-02 |
| Date Added to Maude | 2012-10-04 |
| 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 | 7149613634 |
| 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 | COULTER LH SLIDEMAKER |
| Generic Name | SPINNER, SLIDE, AUTOMATED |
| Product Code | GKJ |
| Date Received | 2012-06-06 |
| Model Number | NA |
| 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 BOULEVARD BREA CA 92821623 US 92821 6232 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-06-06 |