FDA Adverse Event
Malfunction
Summary report: N
CADD SOLIS VIP AMBULATORY INFUSION PUMP
MDR report key: 21000541
·
Received December 23, 2024
Report
- Report Number
- 3012307300-2024-15302
- Event Type
- Malfunction
- Date Received
- December 23, 2024
- Date of Event
- January 1, 2024
- Report Date
- December 23, 2024
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- FRN
- PMA / PMN Number
- K111275
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
B3: EVENT DATE UNKNOWN. DEVICE EVALUATION: ONE DEVICE WAS RECEIVED IN USED CONDITION. DURING THE FUNCTIONAL TESTING, THE REPORTED PROBLEM WAS ABLE TO BE DUPLICATED. THE MOST PROBABLE CAUSE IS A CORRODED PWA BOARD. AFTER RUNNING THE MOTOR, THE ERROR CODE INDICATED A PROBLEM WITH THE CAM FLEX SENSOR OR THE PWA BOARD. PWA BOARD WAS FOUND TO HAVE POSSIBLE BATTERY ACID PRESENT, WITH THE CAM FLEX SENSOR REPLACEMENT BEING A PART OF THE PROCEDURE FOR A PWA BOARD. THE PWA BOARD WAS REPLACED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THAT THE DEVICE FLASHED EC 41622 UPON START UP DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/UNKNOWN ADVERSE EVENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 79887 | CADD SOLIS VIP AMBULATORY INFUSION PUMP | PUMP, INFUSION | FRN | SMITHS MEDICAL ASD, INC. | 2120 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |