FDA Adverse Event
Malfunction
Summary report: N
CADD SOLIS VIP PUMP
MDR report key: 14538503
·
Received May 28, 2022
Report
- Report Number
- 3012307300-2022-09993
- 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 CASSETTE LOCKED BUT NOT LATCHED ERROR" PROBLEM WAS NOT DUPLICATED. THE UNIT WAS TESTED BY OPERATING THE ATTACH/DETACH CYCLE MANY TIMES AND THE PUMP WAS FOUND TO BE OPERATING NORMALLY. A MANUFACTURING DHR REVIEW WAS NOT PERFORMED BECAUSE THE RESULTS OF THE COMPLAINT INVESTIGATION DO NOT INDICATE A PROBLEM WITH THE MANUFACTURE OF THE DEVICE.
Description of Event or Problem · 0
ORACLE RO 1230633: 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 |
|---|---|---|---|---|---|---|---|
| 1687768 | CADD SOLIS VIP PUMP | PUMP, INFUSION | FRN | SMITHS MEDICAL ASD, INC. | 2120 | 15019517150001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |