FDA Adverse Event
Injury
Summary report: N
ICU MEDICAL PLUM 360
MDR report key: 23598095
·
Received November 19, 2025
Report
- Report Number
- MW5179091
- Event Type
- Injury
- Date Received
- November 19, 2025
- Date of Event
- November 11, 2025
- Report Date
- November 17, 2025
- Manufacturer
- ICU MEDICAL / ICU MEDICAL COSTA RICA LTD.
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PLUM 360 PUMPS SHUTTING OFF AFTER IT GIVES AN ERROR MESSAGE E30. PUMP THEN WITHOUT ANY WARNING SHUTS OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 314747 | ICU MEDICAL PLUM 360 | PUMP, INFUSION | FRN | ICU MEDICAL / ICU MEDICAL COSTA RICA LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Life Threatening |