FDA Adverse Event
Malfunction
Summary report: N
ALARIS SMARTSITE
MDR report key: 24176703
·
Received January 26, 2026
Report
- Report Number
- 9616066-2026-00103
- Event Type
- Malfunction
- Date Received
- January 26, 2026
- Date of Event
- December 15, 2025
- Report Date
- May 11, 2026
- Manufacturer
- SISTEMAS MEDICOS ALARIS S.A DE C.V.
- Product Code
- FPA
- UDI-DI
- 10885403227998
- PMA / PMN Number
- K221327
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
Additional Manufacturer Narrative · 0
CORRECTION: CATALOG AND BATCH NUMBER PROVIDED. SEE D TAB. PMA/510K: K221327: SEE G TAB.
Description of Event or Problem · 0
IT IS REPORTED BACKFLOW. VERBATIM: SPECIFICALLY RELATED TO THE BACK CHECK VALVE A SET OF PRIMARY TUBING (USED WITH SECONDARY TUBING TO INFUSE POTASSIUM AS PIGGYBACK). UNKNOWN PATIENT HARM.
Description of Event or Problem · 0
NO ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 609190 | ALARIS SMARTSITE | SET, ADMINISTRATION, INTRAVASCULAR | FPA | SISTEMAS MEDICOS ALARIS S.A DE C.V. | 25105330 | 10885403227998 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |