FDA Adverse Event
Other
Summary report: N
AVI 3M IV INFUSION PUMP
MDR report key: 110749
·
Received August 1, 1997
Report
- Report Number
- 2183161-1997-00024
- Event Type
- Other
- Date Received
- August 1, 1997
- Report Date
- July 23, 1997
- Manufacturer
- GRASEBY MEDICAL, INC.
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
RETURNED FOR SERVICE, NOTED THAT DEVICE "PUMPS TOO SLOW" THERE WAS NO REPORT OF USE ON A PT, PT INJURY OR MEDICAL INTERVENTION REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AVI 3M IV INFUSION PUMP | IV INFUSION PUMP | FRN | GRASEBY MEDICAL, INC. | 480 | YP00017 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | IV ADMINISTRATION SET. |