FDA Adverse Event
Malfunction
Summary report: N
CADD SOLIS VIP PUMP
MDR report key: 18793569
·
Received February 27, 2024
Report
- Report Number
- 3012307300-2024-01023
- Event Type
- Malfunction
- Date Received
- February 27, 2024
- Date of Event
- January 1, 2024
- Report Date
- October 8, 2024
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- FRN
- UDI-DI
- 10610586042591
- PMA / PMN Number
- K111275
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
B3: UNKNOWN. H3: DEVICE NOT RECEIVED BY MANUFACTURER. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.
Additional Manufacturer Narrative · 0
WHILE PERFORMING A REVIEW OF THE FILE IT WAS DETERMINED THAT IT WAS A DUPLICATE OF AN EXISTING COMPLAINT RECORD. PLEASE DISREGARD ANY REPORTS ASSOCIATED WITH FILE MRN 3012307300-2024-01023. PLEASE REFERENCE FILE MRN 3012307300-2024-01016-00 FOR ALL DETAILS PERTINENT TO THIS EVENT.
Description of Event or Problem · 0
THE ISSUE REPORTED THE DEVICE EXHIBITED "ERROR CODE 46822". THERE WAS UNKNOWN PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 445873 | CADD SOLIS VIP PUMP | PUMP, INFUSION | FRN | SMITHS MEDICAL ASD, INC. | 2120 | 10610586042591 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |