MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-07 for MDDS/EHR DEVICE manufactured by Pro Touch/kindred.
[25499173]
There was interval increase of potassium level in a case on both potassium supplements and a potassium sparing diuretic for end stage heart failure. A potassium level was 5. 7 yet both the potassium and the diuretic were administered because the high potassium level was not seen having been electronically sent to the mdds without notice or warning. Additional therapy was needed to correct the risk.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5056072 |
| MDR Report Key | 5067746 |
| Date Received | 2015-09-07 |
| Date of Report | 2015-09-07 |
| Date of Event | 2015-08-21 |
| Date Added to Maude | 2015-09-10 |
| 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 | MDDS/EHR DEVICE |
| Generic Name | EHR/MDDS |
| Product Code | NSX |
| Date Received | 2015-09-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRO TOUCH/KINDRED |
| Manufacturer Address | LOUISVILLE KY 40202 US 40202 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Other; 3. Required No Informationntervention | 2015-09-07 |