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