FDA Adverse Event
Malfunction
Summary report: N
CADD-SOLIS VIP AMBULATORY INFUSION PUMP
MDR report key: 24872787
·
Received April 14, 2026
Report
- Report Number
- 3012307300-2026-03688
- Event Type
- Malfunction
- Date Received
- April 14, 2026
- Date of Event
- February 27, 2026
- Report Date
- April 14, 2026
- Manufacturer
- ICU MEDICAL, INC.
- Product Code
- FRN
- UDI-DI
- 15019517150292
- PMA / PMN Number
- K111275
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
H6: CODES WERE ADDED. ONE DEVICE WAS RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT COMPLAINT OF ¿PUMP DOES NOT RECOGNIZE THE CASSETTE", CONFIRMED THROUGH PUMP POWER UP TEST AND ATTACHED A 50 ML CASSETTE. DSO SENSOR WILL NEED TO BE REPLACED. UPON FURTHER INVESTIGATION, FOUND NO OTHER ISSUES. SERVICE HISTORY REVIEW IDENTIFIED THERE WAS NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD.
Description of Event or Problem · 0
(B)(4) WAS OPENED REGARDING A CADD-SOLIS VIP AMBULATORY INFUSION PUMP WITH LN 21-2127-0105-01 AND SN (B)(6): IT WAS REPORTED THAT THE PUMP DOES NOT RECOGNIZE THE CASSETTE. THE EVENT OCCURRED DURING TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 940016 | CADD-SOLIS VIP AMBULATORY INFUSION PUMP | PUMP, INFUSION | FRN | ICU MEDICAL, INC. | 15019517150292 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |