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 2015-08-27 for NAVIOS FLOW CYTOMETER SYSTEM A52103 manufactured by Beckman Coulter Ireland.
[24622392]
The customer was guided through troubleshooting procedures over the phone by a customer technical support (cts) representative. The customer ran flow check standardization beads and the fluorescent peaks were far to the right of the histogram. The cts asked the user to check if the sheath filter had air and discovered that the sheath filter was filled with 1/3 fluid and the rest air. The cts suggested to run idle mode back and forth several times to fill the sheath filter with fluid. The filter filled with fluid, and the flow check beads came within acceptable range. The instrument is operational and no service visit was required. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[24622393]
The customer reported a sheath fluid leak of approximately one liter (1 l) from the sheath filter on a navios flow cytometer system during instrument startup. No error messages were reported at the time of the event. The customer was wearing personal protective equipment (ppe) consisting of laboratory coat, goggles and gloves at the time of the event and 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 effect to patient treatment in connection to the event. There was no impact to patient results and controls.
Patient Sequence No: 1, Text Type: D, B5
[39314406]
The issue in this event occurred on a newly installed device that was being used by the customer for the first time; no patient samples had yet been run on the instrument. During the installation process, the sheath filter is installed onsite by a field service engineer (fse) performing the installation. The mechanism of installation is a quick disconnect, which must be fully inserted into the tubing to provide a fluid tight seal. The instrument's installation service record was reviewed and the record does not indicate any issues that occurred related to the filter installation. The likely cause of this issue is an error by the fse performing the installation consisting of a failure to fully insert the quick disconnect. There is no evidence that this issue was related to the instrument manufacturing process.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2015-01367 |
| MDR Report Key | 5036246 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2015-08-27 |
| Date of Report | 2015-08-03 |
| Date of Event | 2015-08-03 |
| Date Mfgr Received | 2016-02-22 |
| Device Manufacturer Date | 2015-05-01 |
| Date Added to Maude | 2015-08-27 |
| 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 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 | 2015-08-27 |
| Model Number | NA |
| Catalog Number | A52103 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2015-08-27 |