MAUDE Adverse Event Report: FRESENIUS VIAL S.A.S. VOLUMAT MC AGILIA E; INFUSION PUMP SYSTEM

Catalog Number Z019180

Device Problem No Apparent Adverse Event (3189)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/20/2023

Event Type  Injury  

Event Description

The following has been reported: "pump failure while delivering selected volume to be infused.The pump has infused the medication faster than programmed.The infusion was programmed to pass the medication in 24 hours and the pump pass the drug in 1 hours, causing serious problems for the patient.The pump has carried out preventive maintenance (<1 year)." per the customer, additional information about the patient: "subcutaneous infusion medication: morphic chloride, ketorolac, haloperidol, finder, midazolam.The lady died but not from the perfusion she was at the end of her life" device history record was reviewed and nothing was found related to the reported event.Device log was reviewed but nothing linked to the reported event could be identified.The reported device was returned to brézins for investigation.Device log was fully analysed.All datas found showed that calculated volume matches recorded volume.Each identified infused volumes were in line with the device programming.Several functional tests related to the reported event were carried out.All performed successfully and values were found compliant with ifu specifications compared to settings.No functional or technical issue could be identified.This complaint is considered as not valid.For this issue as per our local procedure, we initiated no action.

• Brand Name: VOLUMAT MC AGILIA E
• Type of Device: INFUSION PUMP SYSTEM
• Manufacturer (Section D): FRESENIUS VIAL S.A.S.; le grand chemin; brezins, 38590 ; FR 38590
• MDR Report Key: 16907044
• MDR Text Key: 314953747
• Report Number: 3004548776-2023-00128
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: Z019180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/10/2023
• Distributor Facility Aware Date: 04/20/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/10/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other