FDA Adverse Event
Malfunction
Summary report: N
CADD SOLIS VIP PUMP
MDR report key: 14538511
·
Received May 28, 2022
Report
- Report Number
- 3012307300-2022-09997
- Event Type
- Malfunction
- Date Received
- May 28, 2022
- Report Date
- May 28, 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
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE WAS RETURNED TO SMITHS/ICU MEDICAL. THE REPORTED "CASSETTE DETACHED STAY ON" PROBLEM WAS DUPLICATED. DURING INVESTIGATION, FOUND LATCH/LOCK OPTIC FLEX CIRCUIT WAS NON-FUNCTIONING. THE DEFECTIVE LATCH/LOCK OPTIC FLEX SENSOR. A DHR REVIEW WAS PERFORMED SUBSEQUENT TO THE MANUFACTURING OF THE DEVICE AND PRIOR TO ITS RELEASE. NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THIS DHR REVIEW.
Description of Event or Problem · 0
ORACLE RO 1230626: IT WAS REPORTED THAT A PROBLEM OCCURRED WITH CASSETTE DETACHMENT. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1687776 | CADD SOLIS VIP PUMP | PUMP, INFUSION | FRN | SMITHS MEDICAL ASD, INC. | 2120 | 15019517150001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |