MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-19 for SPECTRUM IQ 3570009 manufactured by Baxter International, Inc..
[136501638]
Pharmacy called to the patient's room to assist in programming the pump for cyclical tpn. Pharmacist noticed that there was quite a lot of tpn remaining in the bag for it be cyclical and questioned the order. Confirmed with rn caring for the patient at the time if the pump was programmed correctly overnight and she did confirm the pump was running at 94. 1 ml/hr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8349469 |
| MDR Report Key | 8349469 |
| Date Received | 2019-02-19 |
| Date of Report | 2019-02-11 |
| Date of Event | 2019-01-19 |
| Report Date | 2019-02-11 |
| Date Reported to FDA | 2019-02-11 |
| Date Reported to Mfgr | 2019-02-19 |
| Date Added to Maude | 2019-02-19 |
| 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 | 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 | 3 |
| Brand Name | SPECTRUM IQ |
| Generic Name | INFUSION SAFETY MANAGEMENT SOFTWARE |
| Product Code | PHC |
| Date Received | 2019-02-19 |
| Model Number | 3570009 |
| Catalog Number | 3570009 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER INTERNATIONAL, INC. |
| Manufacturer Address | 7511 114TH AVENUE NORTH LARGO FL 33773 US 33773 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-19 |