MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-31 for SPECTRUM IQ 3570009 manufactured by Baxter International Inc..
[146641632]
During change of shift intravenous drip handoff and safety check, both rn's noticed the dexmedetomidine bag was completely empty. A new 250ml bag was recently hung by another staff rn on unit. Thirty minutes later, the previous rn and this rn had noticed the bag was already empty and the pump was alarming "air in line. " the settings were checked and confirmed by both rn's. The settings on the pump were all correct, dose of 1. 5 mcg/kg/hr, rate of 28. 13 ml/hr however the whole bag was gone. The volume on the pump still read there was 204ml left. The sigma pump malfunctioned and the patient received 250ml of dexmedetomidine over about a half hour. The patients vital signs were stable and the physician was notified and patient was assessed at the bedside. This rn will continue to monitor patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8658058 |
| MDR Report Key | 8658058 |
| Date Received | 2019-05-31 |
| Date of Report | 2019-05-01 |
| Date of Event | 2019-04-29 |
| Report Date | 2019-05-01 |
| Date Reported to FDA | 2019-05-01 |
| Date Reported to Mfgr | 2019-05-31 |
| Date Added to Maude | 2019-05-31 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 3 |
| Brand Name | SPECTRUM IQ |
| Generic Name | INFUSION SAFETY MANAGEMENT SOFTWARE |
| Product Code | PHC |
| Date Received | 2019-05-31 |
| Model Number | 3570009 |
| Catalog Number | 3570009 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER INTERNATIONAL INC. |
| Manufacturer Address | ONE BAXTER PARKWAY DEERFIELD IL 60015 US 60015 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-31 |