MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-09-17 for NAVIOS FLOW CYTOMETER SYSTEM A52103 manufactured by Beckman Coulter Ireland.
[26112208]
A field service engineer (fse) evaluated the gallios instrument on 09/02/2015. The fse ran the sheath pressure test in cytotools and saw slow reaction times to changes in sheath pressure with an external marsh gauge. The fse replaced the sheath pressure regulator to resolve the issue. Subsequent testing was within specification. The beckman coulter internal identifier for this report is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[26112209]
The customer reported receiving sheath pressure error messages on a gallios flow cytometer system. While troubleshooting the event with the guidance of customer technical support (cts) over the phone, the customer was splashed on the face and arm with sheath fluid. The customer was wearing personal protective equipment (ppe) consisting of laboratory coat and gloves at the time of the event and there was no report of injury or biohazard exposure to open wounds or mucous membranes. The customer did not seek medical attention following the event. The cts representative directed the customer to wash the affected areas thoroughly with water. Erroneous patient results were not generated and there was no change or effect to patient treatment in connection to the event. There was no impact to patient results and controls. This event occurred on the gallios device, which is marketed for research use only (ruo). This report is being filed for similar device, the navios flow cytometer system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1061932-2015-01459 |
| MDR Report Key | 5084978 |
| Report Source | USER FACILITY |
| Date Received | 2015-09-17 |
| Date of Report | 2015-08-31 |
| Date of Event | 2015-08-31 |
| Date Mfgr Received | 2015-08-31 |
| Device Manufacturer Date | 2010-12-01 |
| Date Added to Maude | 2015-09-17 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. MIRANDA HOLLAND |
| Manufacturer Street | 11800 SW 147TH AVENUE, 32-S08 |
| Manufacturer City | MIAMI FL 331962031 |
| Manufacturer Country | US |
| Manufacturer Postal | 331962031 |
| Manufacturer Phone | 3053802031 |
| 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 | NAVIOS FLOW CYTOMETER SYSTEM |
| Generic Name | FLOW CYTOMETRIC REAGENTS AND ACCESSORIES |
| Product Code | OYE |
| Date Received | 2015-09-17 |
| Model Number | NA |
| Catalog Number | A52103 |
| 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 | LISMEEHAN O'CALLAGHAN'S MILLS, COUNTY CLARE EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-17 |