FDA Adverse Event
Malfunction
Summary report: N
CADD-SOLIS VIP AMBULATORY INFUSION PUMP
MDR report key: 24675068
·
Received March 24, 2026
Report
- Report Number
- 3012307300-2026-02837
- Event Type
- Malfunction
- Date Received
- March 24, 2026
- Date of Event
- February 17, 2026
- Report Date
- March 24, 2026
- Manufacturer
- ICU MEDICAL, INC.
- Product Code
- FRN
- UDI-DI
- 15019517126587
- PMA / PMN Number
- K111275
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
ONE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED. FUNCTIONAL TESTING REVEALED A BAD DOWNSTREAM OCCLUSION SENSOR. THE SENSOR WAS REPLACED. THE DEVICE THEN PASSED ALL FUNCTIONAL TESTS. THE SERVICE HISTORY REVIEW HAD NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD.
Description of Event or Problem · 0
US SR 3903502 WAS OPENED REGARDING A CADD-SOLIS VIP AMBULATORY INFUSION PUMP WITH LN 21-2120-0104-01 AND SN (B)(6): IT WAS REPORTED THAT, DURING TESTING, THE PUMP WAS GIVING CASSETTE NOT PROPERLY ATTACHED ERROR. THERE WAS NO PATIENT INVOLVEMENT AND HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 733216 | CADD-SOLIS VIP AMBULATORY INFUSION PUMP | PUMP, INFUSION | FRN | ICU MEDICAL, INC. | 2120 | 15019517126587 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |