FDA Adverse Event
Malfunction
Summary report: N
CADD
MDR report key: 11795139
·
Received May 7, 2021
Report
- Report Number
- 3012307300-2021-04086
- Event Type
- Malfunction
- Date Received
- May 7, 2021
- Date of Event
- March 31, 2021
- Report Date
- May 8, 2021
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- FPA
- UDI-DI
- 15019517161953
- PMA / PMN Number
- K031361
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
INFORMATION RECEIVED A SMITHS MEDICAL AMBULATORY AMBULATORY INFUSION PUMPS/CADD ADMINISTRATION SETS - FLOW STOP UNDER INFUSED REMICADE THAT HAD A VOLUME OF 250 ML TO BE DELIVERED TO THE PATIENT. THE INFUSION ENDED WITH 37 ML LEFT IN RESIDUAL BAG; WHICH WAS CALCULATED AT 15% UNDER. NO PATIENT INJURY WAS REPORTED. COMPLAINT RELATED TO OTHER FILES AND DELIVERY PROGRAMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 685621 | CADD | ADMINISTRATION SETS | FPA | SMITHS MEDICAL ASD, INC. | 94 SPIKE | 15019517161953 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |