MAUDE Adverse Event Report: FRESENIUS VIAL S.A.S. AGILIA SP TIVA TW; INFUSION PUMP SYSTEM

Catalog Number Z018894

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 02/14/2024

Event Type  malfunction  

Event Description

The following has been reported: displayed error number errorerror51-0001 after the device is turned on.Need to replace speaker.Reporting as a conservative measure.No adverse event was reported.More information is needed to complete the investigation.

• Brand Name: AGILIA SP TIVA TW
• Type of Device: INFUSION PUMP SYSTEM
• Manufacturer (Section D): FRESENIUS VIAL S.A.S.; le grand chemin; brezins, 38590 ; FR 38590
• Manufacturer (Section G): FRESENIUS VIAL S.A.S.; le grand chemin; brezins, 38590 ; FR 38590
• Manufacturer Contact: rebecca mccandless ; 3 corporate drive; lake zurich, IL 60047-8930 ; 8475502913
• MDR Report Key: 18879835
• MDR Text Key: 337780634
• Report Number: 3000240707-2024-00062
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K121613
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: Z018894
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/27/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1