MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-12 for EMED SCIG60 INFUSER AMBULATORY PUMP manufactured by Emed Technologies Corporation.
[142217604]
Pt infused subq hizentra dose over 15 mins, however, the calculated infusion per versarate calculator should have lasted roughly 2 hours. Pt infused using infuset 930 tubing and scig60 pumps. Infusion was done with nurse on hand administering the infusion. Integrated medical systems. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085862 |
| MDR Report Key | 8515231 |
| Date Received | 2019-04-12 |
| Date of Report | 2019-04-09 |
| Date of Event | 2019-04-09 |
| Date Added to Maude | 2019-04-15 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Brand Name | EMED SCIG60 INFUSER AMBULATORY PUMP |
| Generic Name | IMMUNOGLOBULIN G (IGG) INFUSION SYSTEM |
| Product Code | PKP |
| Date Received | 2019-04-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EMED TECHNOLOGIES CORPORATION |
| Brand Name | INFUSET 930 RATE TUBING |
| Generic Name | SET, ADMINISTRATION, INTRAVASCULAR |
| Product Code | FPA |
| Date Received | 2019-04-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | EMED TECHNOLOGIES CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-12 |