MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-12-13 for SIEMENS PHARMACY manufactured by Siemens.
[1827678]
Pt has a known adverse reaction to albuterol. The allergy is listed in innumerable places in the electronic medical record. Yet, it was ordered by a physician and was listed on the electronic medication record to be given every 2 hours prn, having bypassed the pharmacists' and nurses' recognition. This raises matters of disease of the e-pharmacy and e-medication systems and distrust for the said system of care that is proclaimed to be safer when electronic care administering medical contrivances are deployed. We are concerned that if such a basic error is allowed to go unrecognized by these supposedly safe devices, how safe are they, exactly?
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5018596 |
| MDR Report Key | 1931378 |
| Date Received | 2010-12-13 |
| Date of Report | 2010-12-13 |
| Date of Event | 2010-12-11 |
| Date Added to Maude | 2010-12-22 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIEMENS PHARMACY |
| Generic Name | SOARIAN/INVISION EHR |
| Product Code | LMD |
| Date Received | 2010-12-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS |
| Manufacturer Address | MALVERN PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-12-13 |