CADD-SOLIS VIP AMBULATORY INFUSION PUMP
Report
- Report Number
- 3012307300-2024-11818
- Event Type
- Malfunction
- Date Received
- October 23, 2024
- Date of Event
- September 1, 2024
- Report Date
- February 25, 2025
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- FRN
- UDI-DI
- 10610586042829
- PMA / PMN Number
- K111275
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
B3: UNKNOWN; NO INFORMATION HAS BEEN PROVIDED TO DATE. E: PHONE NUMBER EXTENSION (B)(6). INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
UPDATED SECTION A. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.
CORRECTION TO PREVIOUS SUPPLEMENTAL REPORT (3012307300-2024-11818): AWARE DATE FOR RECEIPT OF ADDITIONAL INFORMATION IS 03-FEB-2025.
H3: THE DEVICE WAS RECEIVED FOR EVALUATION. SERVICE HISTORY REVIEW IDENTIFIED THERE WAS NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. A REVIEW OF THE EVENT HISTORY LOG FOUND MULTIPLE OCCURRENCES OF SYSTEM FAULT 41541 ERROR CODES. VISUAL AND FUNCTIONAL TESTS WERE PERFORMED, AND A WORN-OUT LATCH HANDLE, LATCH LOCK AND LATCH FLEX SENSOR WERE FOUND TO BE THE CAUSE OF THE ISSUE. THE ENTIRE LATCH LOCK ASSEMBLY WAS REPLACED TO FIX THE ISSUE.
IT WAS REPORTED THAT THE DEVICE HAD ERROR CODE 141514. THERE WAS UNKNOWN PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 296523 | CADD-SOLIS VIP AMBULATORY INFUSION PUMP | PUMP, INFUSION | FRN | SMITHS MEDICAL ASD, INC. | 2120 | 10610586042829 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |