FDA Adverse Event
Malfunction
Summary report: N
CADD SOLIS VIP PUMP
MDR report key: 14538515
·
Received May 28, 2022
Report
- Report Number
- 3012307300-2022-09999
- 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 DEVICE IS CHECKED WITH IN HOUSE CASSETTE AND UNABLE TO REPEAT THE CUSTOMER ISSUE OF CASSETTE LOOSE." THE CUSTOMER DID NOT RETURNED THE CASSETTE FOR EVALUATION. 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 1230611: IT WAS REPORTED THAT THE CASSETTE WAS LOOSE. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1687780 | CADD SOLIS VIP PUMP | PUMP, INFUSION | FRN | SMITHS MEDICAL ASD, INC. | 2120 | 15019517150001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |