FDA Adverse Event
Malfunction
Summary report: N
CADD MEDICATION CASSETTE RESERVOIRS WITH FLOW STOP
MDR report key: 8035204
·
Received November 2, 2018
Report
- Report Number
- 3012307300-2018-08115
- Event Type
- Malfunction
- Date Received
- November 2, 2018
- Date of Event
- April 24, 2018
- Report Date
- April 14, 2019
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- FRN
- UDI-DI
- 10610586022128
- PMA / PMN Number
- K843772
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 0
ONE CADD CASSETTE WAS RETURNED FOR ANALYSIS IN USED CONDITION. VISUAL INSPECTION OF THE SET FOUND NO DISCREPANCIES. LEAK TESTING IDENTIFIED LEAKAGE FROM ONE OF THE TOP CORNERS OF AY BAG. BASED ON THE EVIDENCE, THE COMPLAINT WAS CONFIRMED. THE PROBLEM SOURCE OF THE EVENT WAS IDENTIFIED AS MANUFACTURING.
Description of Event or Problem · 1
INFORMATION WAS RECEIVED THAT THE CADD CASSETTE IS LEAKING INSIDE THE CASSETTE. NO ADVERSE PATIENT EFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 873165 | CADD MEDICATION CASSETTE RESERVOIRS WITH FLOW STOP | PUMP, INFUSION | FRN | SMITHS MEDICAL ASD, INC. | 18X055 | 10610586022128 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |