MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-25 for ELECTRONIC MEDICAL RECORD manufactured by Epic.
[46407640]
The ehr mdds component fails to provide adequate notice that new lab results have been deposited; and more dangerous, there is zero notice that the silently deposited results have life threatening implications. In this case of atrial fibrillation being treated with heparin and being converted to coumadin (receiving both drugs), the hemoglobin was 7. 0 g/dl on a 6 am blood draw. The result was in the silo of the ehr, but no one saw it because they all rounded earlier. It was more than 12 hours later that it was seen by a health care professional, during which time full heparin infusion continued. The heparin was stopped at the time the results were seen but the coumadin had already been administered. The next morning, the hemoglobin was less than 6 g/dl, the patient was bleeding from the gi tract, and there was incipient shock requiring icu transfer. The device was defective in that it failed to alert of new results, which resulted in delay of appropriate care.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5062551 |
| MDR Report Key | 5690723 |
| Date Received | 2016-05-25 |
| Date of Report | 2016-05-25 |
| Date of Event | 2016-05-23 |
| Date Added to Maude | 2016-06-01 |
| 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 | ELECTRONIC MEDICAL RECORD |
| Generic Name | EHR/MDDS |
| Product Code | NSX |
| Date Received | 2016-05-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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. Hospitalization; 2. Life Threatening; 3. Other; 4. Required No Informationntervention | 2016-05-25 |