FDA Adverse Event
Injury
Summary report: N
CADD LEGACY PUMP
MDR report key: 11634025
·
Received April 7, 2021
Report
- Report Number
- MW5100652
- Event Type
- Injury
- Date Received
- April 7, 2021
- Report Date
- March 8, 2021
- Manufacturer
- SMITHS MEDICAL ASD, INC
- Product Code
- FRN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
SPONTANEOUS CALL FROM (B)(6) HOSPITAL WEIGHT: (B)(6) KG, (B)(6) CALLED TO GET INFORMATION ON CURRENT DOSE. ALSO STATED THAT PATIENT WAS IN THE HOSPITAL DUE TO PUMP ISSUE (B)(6) DID NOT KNOW ANY FURTHER DETAILS. DID NOT PROVIDED PUMP SERIAL NUMBER. NO OTHER INFORMATION OR DATES PROVIDED. REPORTED TO (B)(6) BY: HEALTH PROFESSIONAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 523014 | CADD LEGACY PUMP | PUMP, INFUSION | FRN | SMITHS MEDICAL ASD, INC | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |