MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-11-01 for NAVIOS FLOW CYTOMETER SYSTEM A71848 manufactured by Beckman Coulter Ireland.
[58937316]
A field service engineer (fse) evaluated the instrument. The fse found that the sheath sensor was faulty and was causing a leak. The fse replaced the sheath sensor, which repaired the leak. The repairs were verified by the fse. The gallios instrument is a research use only (ruo) instrument in (b)(6). However, the navios instrument is a similar instrument and is used in (b)(6) and the us for in vitro diagnostics (ivds). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[58937317]
The customer reported a leak from the gallios flow cytometer. The volume of the leak was about 200 ml and was not contained within the instrument. The customer was wearing personal protective equipment (ppe) consisting of laboratory coat and gloves at the time of the event. There was no report of injury or biohazard exposure to open wounds or mucous membranes. Erroneous patient results were not generated and there was no change or affect to patient treatment in connection with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1061932-2016-00937 |
| MDR Report Key | 6070751 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-11-01 |
| Date of Report | 2016-10-07 |
| Date of Event | 2016-10-07 |
| Date Mfgr Received | 2016-10-07 |
| Device Manufacturer Date | 2009-09-01 |
| Date Added to Maude | 2016-11-01 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. MIRANDA HOLLAND |
| Manufacturer Street | 11800 SW 147TH AVE 32-L23 |
| Manufacturer City | MIAMI FL 33196 |
| Manufacturer Country | US |
| Manufacturer Postal | 33196 |
| Manufacturer Phone | 3053802031 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 11800 SW 147TH AVE |
| 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 | NAVIOS FLOW CYTOMETER SYSTEM |
| Generic Name | FLOW CYTOMETRIC REAGENTS AND ACCESSORIES |
| Product Code | OYE |
| Date Received | 2016-11-01 |
| Model Number | NA |
| Catalog Number | A71848 |
| Lot 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 IRELAND |
| Manufacturer Address | 250 SOUTH KRAEMER BLVD. LISMEEHAN O'CALLAGHAN'S MILLS COUNTY CLARE, EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-01 |