FDA Adverse Event Malfunction Summary report: N

AGILIA SP MC FR

MDR report key: 17667446 · Received August 31, 2023

Report

Report Number
3004548776-2023-00267
Event Type
Malfunction
Date Received
August 31, 2023
Date of Event
July 26, 2023
Report Date
August 31, 2023
Manufacturer
FRESENIUS VIAL S.A.S.
Product Code
FRN
Product Problem
Yes
Report Source
Distributor report
Reporter Location
FR
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 0

THE FOLLOWING HAS BEEN REPORTED: INCONSISTENCY IN THE DATA DISPLAYED (TIME REMAINING TO INFUSION AND VOLUME REMAINING TO BE INFUSED) ON THE SYRINGE PUMP DURING AN INFUSION. AN INFUSION WAS STARTED WITH THIS SYRINGE PUMP ON (B)(6) 2023 AT 3PM. THE SYRINGE PUMP WAS PROGRAMMED AT A SPEED OF 2 ML/H WITH A SYRINGE CONTAINING 24 ML OF HEPARIN. AFTER PURGING, A VOLUME OF 4 ML REMAINED IN THE TUBING. THIS LEFT 20ML IN THE SYRINGE WHEN THE INFUSION WAS STARTED AT 3PM. THE DURATION OF THE INFUSION SHOULD THEREFORE HAVE BEEN 10 HOURS, WITH THE INFUSION ENDING AT 1AM ON (B)(6) 2023. WHEN A NURSE VISITED THE PATIENT'S ROOM AT 10.30PM ON (B)(6) 2023, SHE NOTICED THE FOLLOWING INCONSISTENCY IN THE DATA ON THE SYRINGE PUMP: PROGRAMMED SPEED OF 2 ML/H : OK. END OF INFUSION IN 1.5 HOURS. THIS WOULD MEAN THAT THE INFUSION WOULD END ON (B)(6) 2023 AT 00:00 (AND NOT 1:00 AS INITIALLY PLANNED). A VOLUME OF 8 ML REMAINS TO BE INFUSED. THE END-OF-INFUSION TIME INDICATED ON THE SYRINGE PUMP SHOULD HAVE BEEN (8ML DIVIDED BY 2ML/H), 4 HOURS AND NOT 1.5 HOURS AS INDICATED ON THE SYRINGE PUMP. WE WOULD LIKE A STUDY OF OUR EQUIPMENT FOR THE WHOLE OF THIS INFUSION, WITH A FOCUS ON 10:30PM ON (B)(6) 2023 IN ORDER TO KNOW PRECISELY THE END OF THE INFUSION AND THE VOLUME REMAINING IN THE SYRINGE, DISPLAYED ON THE SYRINGE PUMP. WE WOULD LIKE TO BE SURE THAT THIS SYRINGE PUMP IS COMPLIANT." REPORTING AS A CONSERVATIVE MEASURE DUE TO THE REFERENCED ISSUES. THERE WERE NO REPORTS OF AN ADVERSE EVENT. MORE INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1183965 AGILIA SP MC FR INFUSION PUMP SYSTEM FRN FRESENIUS VIAL S.A.S.

Patients

Seq Age Sex Outcome Treatment
1 Unknown