MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-17 for SYSMEX WORK AREA MANAGEMENT SYSTEM WAM VERSION 5.0.2 WAM 5.0.2 manufactured by Sysmex America Inc..
[188808219]
When processing body fluids, the operator selects the color from a list of options defined by the site in the "color csf" field. These options included amber, brown, condition of specimen makes cell count impossible, colorless, other, pink, red and xanthochromic. The operator also selected a result for the "xanthochromic" field. The options included absent, condition of specimen makes cell count impossible or present. In this case, the operator selected "xanthochromic" for the "color csf" field but selected "absent" for the "xanthochromic" field. Sysmex wam is a hematology information management system that offers a comprehensive analyzer and result management tool. Sysmex wam consolidates data from multiple analyzers, performs complex rules-based functions, aids the technologist in results review/data interpretation, and then sends this information to the laboratory information system (lis). However, it is the user's responsibility to test all workflow and rules prior to implementation. User error caused this event. Wam performed as designed.
Patient Sequence No: 1, Text Type: N, H10
[188808220]
An operator of work area manager (wam) system middleware version 5. 02 selected "xanthochromia" from the options for the "color csf" field on a cerebral spinal fluid (csf). The operator also incorrectly selected "absent" from options for the "xanthochromia" field. Erroneous results were reported. A corrected report was issued changing the xanthochromia result to "present". The operator alleged a delay in multiple treatments due to the erroneous results being released to the medical team. The treatments included nimodipine initiation, placement of an external ventricular drain, and admission to the neuro intensive care unit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000515253-2020-00012 |
| MDR Report Key | 9841725 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-02-05 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2019-05-29 |
| Date Added to Maude | 2020-03-17 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. NANCY GOULD |
| Manufacturer Street | 577 APTAKISIC RD |
| Manufacturer City | LINCOLNSHIRE, IL |
| Manufacturer Country | US |
| Manufacturer Phone | 5439678 |
| Manufacturer G1 | SYSMEX AMERICA INC. |
| Manufacturer Street | 577 APTAKISIC RD |
| Manufacturer City | LINCOLNSHIRE, IL |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYSMEX WORK AREA MANAGEMENT SYSTEM |
| Generic Name | MIDDLEWARE |
| Product Code | OUG |
| Date Received | 2020-03-17 |
| Model Number | WAM VERSION 5.0.2 |
| Catalog Number | WAM 5.0.2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYSMEX AMERICA INC. |
| Manufacturer Address | 577 APTAKISIC RD LINCOLNSHIRE, IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-17 |