MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-23 for EM2400 DY DISPLAY 2400-DY manufactured by Baxter Healthcare Corporation.
[184473474]
Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[184473475]
It was reported the dextrose and the sterile water? Inlets were switched" during the compounding of total parenteral nutrition (tpn) bags with an exactamix automated compounding device. During tpn administration, the neonate patient experienced elevated blood glucose levels. Subsequently, the infusion was stopped mid infusion. The patient was treated with intravenous insulin (2 single doses, no further details). It was reported the patient did not experience any signs or symptoms related to the elevated blood glucose levels. At the time of this report, the patient was recovered from the event. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[188118263]
The device was not received for evaluation; therefore, a device analysis could not be completed; however, the compounder black box data was evaluated. Upon data evaluation, there was no evidence that the compounder or the compounder software contributed to the reported event of the patient receiving the incorrect drugs via switching of the inlets. The data provided showed that the bag produced by this compounder, without any environmental or physical interference, should have been acceptable for clinical use. The device functioned as intended from what was observed from the black box information. The reported condition was not verified. It is possible that the reported event was due to a use error. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416980-2020-01627 |
| MDR Report Key | 9865744 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-02-15 |
| Date Mfgr Received | 2020-02-25 |
| Date Added to Maude | 2020-03-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 2242702068 |
| Manufacturer G1 | BAXTER HEALTHCARE - ENGLEWOOD |
| Manufacturer Street | 14445 GRASSLANDS DR |
| Manufacturer City | ENGLEWOOD CO 80112 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80112 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EM2400 DY DISPLAY |
| Generic Name | SYSTEM/DEVICE, PHARMACY COMPOUNDING |
| Product Code | NEP |
| Date Received | 2020-03-23 |
| Model Number | NA |
| Catalog Number | 2400-DY |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | DEERFIELD IL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-23 |