MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-12-08 for EPIC manufactured by .
[5245156]
A nicu pt was given 12. 5 meq of calcium in d12. 5 100 ml for iv administration. This caused the baby to receive 5x the amount of calcium, because the calcium should have been in 500 ml of d12. 5. The baby's calcium went up to 16. 4 because of this incident. A recommendation to prevent this in the future is to make sure 12. 5 meq of calcium can only be paired with 500 ml of d12. 5 in epic when ordering this product. Where did the error occur: hospital. Hospital unit: neonatal icu. (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5039448 |
| MDR Report Key | 4323051 |
| Date Received | 2014-12-08 |
| Date of Report | 2014-10-09 |
| Date Added to Maude | 2014-12-12 |
| 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 | 0 |
| Health Professional | 0 |
| 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 | EPIC |
| Generic Name | NONE |
| Product Code | NSX |
| Date Received | 2014-12-08 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-08 |