FDA Adverse Event
Malfunction
Summary report: N
IVENIX INFUSION SYSTEM
MDR report key: 25220129
·
Received May 19, 2026
Report
- Report Number
- 3014732157-2026-02192
- Event Type
- Malfunction
- Date Received
- May 19, 2026
- Date of Event
- April 29, 2026
- Report Date
- May 26, 2026
- Manufacturer
- FRESENIUS KABI USA LLC
- Product Code
- FRN
- UDI-DI
- 00811505030320
- PMA / PMN Number
- K183311
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
THE FOLLOWING HAS BEEN REPORTED: BIOMED REPORTED: "BLUE SCREEN PUMP FAILURE" OBF PUMP FOR SSM. PUMP NEVER USED ON PT. A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: PNEUMATIC VALVE ACTUATION FAILURE (VALVE 6) AN ACTIVE INFUSION WAS NOT STOPPED. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 616825 | IVENIX INFUSION SYSTEM | LARGE VOLUME PUMP (LVP) | FRN | FRESENIUS KABI USA LLC | LVP-0004 | 00811505030320 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |