MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-31 for SPECTRUM IQ manufactured by Baxter Healthcare Corporation.
[134594538]
Patient transferred from emergency department at 1200 with a full levophed bag. Dose was running at 30mcgs/hr. At 1600 pump ran infusion complete. Levophed bag was still full, the clamp above the pump was noted to be clamped and pump never alarmed upstream occlusion. The pump had originally alarmed for a downstream occlusion multiple times and then stopped when the infusion changed to another site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8292479 |
| MDR Report Key | 8292479 |
| Date Received | 2019-01-31 |
| Date of Report | 2019-01-15 |
| Date of Event | 2018-12-05 |
| Report Date | 2019-01-15 |
| Date Reported to FDA | 2019-01-15 |
| Date Reported to Mfgr | 2019-01-31 |
| Date Added to Maude | 2019-01-31 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 2019-01-31 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | ONE BAXTER PARKWAY DEERFIELD IL 60015 US 60015 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-31 |