MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-31 for SUNRISE manufactured by Allscripts.
[30458615]
Repeatedly, abnormal serum potassium levels come in to the ehr but no one knows they are there or that they are abnormal. There is a deficiency in this medical device in that it fails to provide notification that new results have appeared or that they are abnormal. Consequently, the nurses administer medications that exacerbate the abnormal lab value. For instance, potassium and/or potassium sparing medications are administered when the potassium is already too high, putting the patient at extreme risk, and requiring corrective treatments.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5057655 |
| MDR Report Key | 5201306 |
| Date Received | 2015-10-31 |
| Date of Report | 2015-10-31 |
| Date of Event | 2015-10-14 |
| Date Added to Maude | 2015-11-04 |
| 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 | SUNRISE |
| Generic Name | EHR/MDDS |
| Product Code | NSX |
| Date Received | 2015-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLSCRIPTS |
| Manufacturer Address | RALEIGH NC 27615 US 27615 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2015-10-31 |