CADD SOLIS VIP PUMP
Report
- Report Number
- 3012307300-2022-10820
- Event Type
- Malfunction
- Date Received
- June 6, 2022
- Report Date
- August 8, 2022
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- FRN
- UDI-DI
- 15019517150001
- PMA / PMN Number
- K111275
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE DEVICE WAS RETURNED TO SMITHS/ICU MEDICAL.
EVENT PROBLEM AND EVALUATION CODES: UPDATED DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. A VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. VISUAL INSPECTION FOUND THE DEVICE WAS MISSING THE TAMPER SEAL. THE CUSTOMER STATED PROBLEM WAS DUPLICATED. DURING INVESTIGATION, FOUND LATCH/LOCK OPTIC FLEX CIRCUIT NON-FUNCTIONING. REPLACED DEFECTIVE LATCHED OPTIC FLEX SENSOR. THE CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED. A MANUFACTURING DHR 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 CUSTOMER'S REPORTED PROBLEM DURING THE REVIEW OF SERVICE AND REPAIR RECORDS. THEREFORE, NO MANUFACTURING OR SERVICE RECORDS REVIEW IS NEEDED.
ADDITIONAL INFORMATION RECEIVED BY SMITHS MEDICAL/ICU ON 3-JUN-2022 VIA EMAIL AND ATTACHED TO COMPLAINT OBJECT: THE ISSUE WAS NOTED DURING USE WITH A PATIENT. THERE WAS NO PATIENT INJURY AS A RESULT. NO FURTHER INFORMATION IS AVAILABLE FROM THE CUSTOMER.
ORACLE RO 1233076: IT WAS REPORTED THAT THE PUMP WAS NOT DETECTING THE CASSETTE. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 227026 | CADD SOLIS VIP PUMP | PUMP, INFUSION | FRN | SMITHS MEDICAL ASD, INC. | 2120 | 15019517150001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |