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

Catalog Number Z019040

Device Problem No Apparent Adverse Event (3189)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 03/24/2023

Event Type  malfunction  

Event Description

The following has been reported: "patient on noradrenaline.Pre-infusion/obstruction alarm and even after review of all connections, did not get no resolution.The pump change was required.Patient presents with severe hypotension." reporting due to the referenced issue; no further information regarding the patient's condition was communicated.More information is needed to complete the investigation.

Event Description

Device history record was reviewed and nothing was found related to the reported event.Device log was reviewed but data is insufficient to confirm the reported event.The reported device was not returned to brézins for investigation and no information regarding any local repairs was provided.Device log was reviewed and events occuring on event reported date march 24th, 2023 were analysed.Several downstream pre-alarms and alarms confirms the reported event however after last downstream occlusion alarm at 16:18, there was no more pressure alarms during all the afternoon and following night, so it seems that issue on installation has been fixed, and the pump had no more false detection.Therefore, as we did not receive the reported device for further investigation, it's not possible to determine if occlusions alarms were due to utilization/environment or a false detection of the pump.Nevertheless, in case of pressure sensor abnormal drift, a technical error would be triggered, which is not seen in the device log.Despite several requests for the device return and attempts to collect additional information, we did not receive anything that would allow us to identify the actual root cause of this event.This complaint is considered as valid.The trend is normal.The reported risk is lower compared to the estimated risk.For this issue as per our local procedure, we initiated no action.

• Brand Name: VOLUMAT AGILIA BR
• Type of Device: INFUSION PUMP SYSTEM
• Manufacturer (Section D): FRESENIUS VIAL S.A.S.; le grand chemin; brezins, 38590 ; FR 38590
• MDR Report Key: 16801784
• MDR Text Key: 313908203
• Report Number: 3004548776-2023-00111
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: Z019040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/01/2023
• Distributor Facility Aware Date: 03/27/2023
• Event Location: Hospital
• Date Report to Manufacturer: 09/01/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1