FDA Adverse Event
Malfunction
Summary report: N
CADD SOLIS VIP PUMP
MDR report key: 14538500
·
Received May 28, 2022
Report
- Report Number
- 3012307300-2022-09992
- 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 LOCKED BUT NOT LATCHED ERROR" PROBLEM WAS DUPLICATED. THE LATCH/LOCK OPTIC FLEX CIRCUIT SENSOR WAS DEFECTIVE, AND IT WAS REPLACED. 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 1230608: IT WAS REPORTED THAT THE CASSETTE LOCKED BUT DID NOT LATCH. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1687765 | CADD SOLIS VIP PUMP | PUMP, INFUSION | FRN | SMITHS MEDICAL ASD, INC. | 2120 | 15019517150001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |