FDA Adverse Event
Malfunction
Summary report: N
SMITHS MEDICAL CADD LEGACY PLUS PUMP
MDR report key: 9241356
·
Received October 25, 2019
Report
- Report Number
- 3012307300-2019-04245
- Event Type
- Malfunction
- Date Received
- October 25, 2019
- Date of Event
- September 24, 2019
- Report Date
- January 29, 2020
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- FRN
- UDI-DI
- 10610586019647
- PMA / PMN Number
- K982836
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
INFORMATION WAS RECEIVED THAT THE INITIAL PROGRAMMING OF A SMITHS MEDICAL CADD LEGACY PLUS INFUSION PUMP WAS 1190 ML AT 16.5 ML EACH HOUR TO INFUSE OVER A PERIOD OF THREE DAYS. PUMP WAS REPORTED TO BE INFUSING CEF-ANITBIOTIC. PATIENT HAD A RESERVOIR VOLUME OF 18. AND UPSTREAM SENSOR WAS CONFIRMED TO BE ON, AND PATIENT HAD CONFIRMED NO ALARM SOUNDED DURING INFUSION. NO PATIENT INJURY RESULTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1031436 | SMITHS MEDICAL CADD LEGACY PLUS PUMP | PUMP, INFUSION | FRN | SMITHS MEDICAL ASD, INC. | 21-6500-51 | 10610586019647 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | CADD ADMIN SET: 21-7394-24 LOT NUMBER: 3840859 |