FDA Adverse Event
Injury
Summary report: N
ICU MEDICAL PLUM 360
MDR report key: 20757979
·
Received November 21, 2024
Report
- Report Number
- MW5162784
- Event Type
- Injury
- Date Received
- November 21, 2024
- Date of Event
- June 6, 2024
- Report Date
- November 19, 2024
- Manufacturer
- ICU MEDICAL COSTA RICA LTD.
- Product Code
- FRN
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NJ, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
ICU MEDICAL PLUM 360 PUMP: PATIENT HAD A CARDIZEM DRIP INFUSING AND THE PUMP TURNED OFF WITHOUT ANY NOTIFICATION. PUMP OFF BUT CONTINUED TO ALARM WITH NO ABILITY TO SHUT OFF; NO WARNING SIGN OF THIS OCCURRING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2221500 | ICU MEDICAL PLUM 360 | PUMP, INFUSION | FRN | ICU MEDICAL COSTA RICA LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Female | Hospitalization |