FDA Adverse Event
Malfunction
Summary report: N
CADD
MDR report key: 14599324
·
Received June 4, 2022
Report
- Report Number
- 3012307300-2022-10723
- Event Type
- Malfunction
- Date Received
- June 4, 2022
- Date of Event
- April 25, 2022
- Report Date
- June 4, 2022
- Manufacturer
- ST PAUL
- Product Code
- FPA
- UDI-DI
- 10610586027239
- PMA / PMN Number
- K040636
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
DEVICE EVALUATION: NO PRODUCT WAS RETURNED. WE ARE UNABLE TO CONFIRM THE REPORTED COMPLAINT. IF THE PRODUCT IS RETURNED, SMITHS MEDICAL WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.
Description of Event or Problem · 0
IT WAS REPORTED -NO DISPOSABLE PUMP- ALARM ON 4/24/2022 WITH BOTH CADD LEGACY PUMP SERIAL NUMBERS (B)(4) AND (B)(4) AND CADD CASSETTE LOT NUMBER 4220003, EXPIRATION DATE 11/24/2026. CASSETTE WAS PLACED AT 10:30PM AND ALARM OCCURRED APPROXIMATELY 1.5 HOURS LATER. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 323598 | CADD | SET, ADMINISTRATION, INTRAVASCULAR | FPA | ST PAUL | 21-7302-24 | 4220003 | 10610586027239 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |