MAUDE Adverse Event Report: FRESENIUS VIAL S.A.S. INJECTOMAT AGILIA RC2; INFUSION PUMP SYSTEM

Catalog Number Z018097

Device Problems No Apparent Adverse Event (3189); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/13/2023

Event Type  malfunction  

Event Description

The following has been reported: "on (b)(6) 2023, when preparing the [drug] infusion to the patient by pump, the pump failed to turn on and alarm occurred.Then the operator used another pump to continue the infusion." reporting due to the referenced issue as a conservative measure.No adverse event reported.More information is needed to complete the investigation.

• Brand Name: INJECTOMAT AGILIA RC2
• Type of Device: INFUSION PUMP SYSTEM
• Manufacturer (Section D): FRESENIUS VIAL S.A.S.; le grand chemin; brezins, 38590 ; FR 38590
• MDR Report Key: 18017145
• MDR Text Key: 326678610
• Report Number: 3004548776-2023-00340
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: Z018097
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/26/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/26/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1