CADD SOLIS VIP PUMPS
Report
- Report Number
- 3012307300-2022-10715
- Event Type
- Malfunction
- Date Received
- June 3, 2022
- Report Date
- September 28, 2022
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- FRN
- UDI-DI
- 15019517150292
- PMA / PMN Number
- K111275
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
OTHER, OTHER TEXT: H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER: UPDATED. H10: THE DEVICE WAS RETURNED FOR INVESTIGATION. THE REPORTED PROBLEM WAS NOT RELATED TO ANY PREVIOUS REPAIR. VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. VISUAL INSPECTION OF THE DEVICE SHOWED THAT THE TAMPER SEAL WAS MISSING. THERE WAS NO EVIDENCE OF THE REPORTED PROBLEM IN EVENT LOG. FUNCTIONAL TESTING DID NOT CONFIRM THE CUSTOMERS REPORTED PROBLEM AS PROBLEM WAS NOT DUPLICATED. NO PROBLEM WAS FOUND WITH THE DEVICE; HOWEVER, PREVENTATIVE MEASURES WERE PERFORMED. THE ROOT CAUSE OF THE REPORTED PROBLEM IS UNKNOWN. A MANUFACTURING DEVICE HISTORY RECORD REVIEW WAS NOT PERFORMED BECAUSE THE RESULTS OF THE COMPLAINT INVESTIGATION DO NOT INDICATE A PROBLEM WITH THE MANUFACTURE OR LAST REPAIR OF THE DEVICE. NO MANUFACTURING OR SERVICE ISSUES WERE IDENTIFIED AS CAUSES OF THE CUSTOMERS REPORTED PROBLEM DURING THE REVIEW OF SERVICE AND REPAIR RECORDS. THEREFORE, NO MANUFACTURING OR SERVICE RECORDS REVIEW IS NEEDED., CORRECTED DATA: CORRECTIONS: D1: BRAND NAME: CADD SOLIS VIP PUMPS; D4: MODEL NUMBER: 2120; G5:PMA/510(K): K111275.
IT WAS REPORTED THAT A VOLUME INACCURACY WAS EXPERIENCED. UNDER-INFUSES. FAILED DURING TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 335174 | CADD SOLIS VIP PUMPS | PUMP,INFUSION | FRN | SMITHS MEDICAL ASD, INC. | 2120 | 15019517150292 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |