MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-06-10 for MEDFUSION 2010 SYRINGE INFUSION PUMP NA manufactured by Medex.
[30497645]
The reporter stated that dobutamine infusion ordered for newborn ((b)(6) weeks gestation) at 0. 31cc/hr. The syringe pump was programmed in error at 31cc/hr. Approximately 5 minutes later the pt's heart rate and oxygen saturation dropped, requiring bagging and chest compressions. Epinephrine x2, normal saline bolus, calcium gluconate, and sodium bicarb was given. Baby became and remained hypotensive. Supportive critical care continued.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5200911 |
| MDR Report Key | 5200911 |
| Date Received | 2004-06-10 |
| Date of Report | 2004-05-24 |
| Date of Event | 2004-04-16 |
| Date Facility Aware | 2004-04-16 |
| Report Date | 2004-05-24 |
| Date Added to Maude | 2015-11-04 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | MEDFUSION 2010 SYRINGE INFUSION PUMP |
| Generic Name | SYRINGE INFUSION PUMP |
| Product Code | FIH |
| Date Received | 2004-06-10 |
| Model Number | 2010 |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDEX |
| Manufacturer Address | 4350 RIVER GREEN PARKWAY, SUITE 200 DULUTH GA 30096 US 30096 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2004-06-10 |