MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-01 for EHR manufactured by Epic.
[39647862]
The clinical decision support device mitigating drug therapy for all pts has poorly usable functionality such that it pressures the user and defaults to heparin therapy for protection from thrombosis, but fails to consider the frequent situations when the pt is already on an anticoagulant such as warfarin or noacs. It requires a significant amount of clinician time to click the way out of the morass of the flawed decision tree to cancel heparin. It is sufficiently onerous that it is much easier to simply allow the pt to remain over anticoagulated, as was the case in this pt. This puts most pts at higher risk of bleeding events.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5060686 |
| MDR Report Key | 5476570 |
| Date Received | 2016-03-01 |
| Date of Report | 2016-03-01 |
| Date of Event | 2016-02-28 |
| Date Added to Maude | 2016-03-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EHR |
| Generic Name | CLINICAL DECISION SUPPORT |
| Product Code | MMH |
| Date Received | 2016-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EPIC |
| Manufacturer Address | VERONA WI 53593 US 53593 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Other | 2016-03-01 |