FDA Adverse Event Malfunction Summary report: N

CADD

MDR report key: 10410311 · Received August 14, 2020

Report

Report Number
3012307300-2020-08207
Event Type
Malfunction
Date Received
August 14, 2020
Date of Event
June 19, 2020
Report Date
August 14, 2020
Manufacturer
ST PAUL
Product Code
FRN
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
BR
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

INFORMATION RECEIVED A SMITHS MEDICAL AMBULATORY INFUSION PUMPS/CADD LEGACY PLUS PUMPS - 6500 WAS PROGRAMMED ON 06/18 AT 5:55 PM WITH EXPECTED WITHDRAWAL ON 06/19 AT THE SAME TIME, DID NOT GIVE ACCURATE DELIVERY. ON AT 3:30PM THE PATIENT COMES INTO CONTACT WITH THE NURSE REPORTING THAT THE INFUSION BEEPING AS TERMINATION AND COMPLETION EARLY PRIOR TO TIME TO END INFUSION. 5:10PM THE UNIT ARRIVES, WHERE IT IS FOUND THAT THERE IS NO RESIDUAL VOLUME TO BE INFUSED, AND THERE ARE 12.1 ML TO BE INFUSED. INFORMATION WAS COLLECTED AND THE DEVICE WAS PROGRAMMED CORRECTLY. THE VOLUME WAS EMPTY BUT PROGRAM STATED 12.1 ML TO BE DELIVERED. NO LEAKING WAS DETECTED. DOSE: 4914 MG + 23.72 ML 0.9% SODIUM CHLORIDE OF UNKNOWN MEDICATION WAS BEING DELIVERED. NO PATIENT INJURY WAS REPORTED. FINAL VOLUME: 122 ML (W / 2 ML RESIDUE). INFUSER: DELTEC . INFUSION: 120 ML IN 24 H WITH AN INFUSION RATE OF 5 ML / H. THE 2 ML RESIDUAL IS EXPECTED FOR PREVENTING AIR IN LINE. (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
875494 CADD LEGACY FRN ST PAUL 6400

Patients

Seq Age Sex Outcome Treatment
1