MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-12 for SOARIAN manufactured by Siemens.
[23424761]
There was treatment for end stage heart failure that included potassium sparing diuretics, potassium supplements, and other medications listed on heart failure therapy guidelines. Initially, there was syncope with ventricular tachycardia while the potassium was less than normal. It was not until 24 hours after a potassium test result was completed that was 6 meq/l ( up from 5 meq/l one day earlier) that anyone noticed this life threatening metabolic problem. The treatment and medication adjustments resulted in a prolonged hospitalization. The failure of the device to warn of new results renders the ehr mdds not unlike a heart monitor, that requires chronic vigilance to avoid missing a critical arrhythmia. The ehr mdds generally has zero vigilance.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5055473 |
| MDR Report Key | 5011248 |
| Date Received | 2015-08-12 |
| Date of Report | 2015-08-12 |
| Date of Event | 2015-08-08 |
| Device Manufacturer Date | 2013-10-01 |
| Date Added to Maude | 2015-08-18 |
| 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 | SOARIAN |
| Generic Name | MDDS/EHR |
| Product Code | NSX |
| Date Received | 2015-08-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS |
| Manufacturer Address | MALVERN PA 19355 US 19355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2015-08-12 |