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 Extravasation (1842)

Event Date 03/07/2023

Event Type  malfunction  

Event Description

The following has been reported: "there was an extravasation in the peripheral line during the administration of serum therapy and magnesium sulfate and the sato2 alarm of the pump did not go off.The therapy started 15 minutes ago, since the alarm was not activated, the pumps continued perfusing.Consequence: the incident has caused harm to the patient.The patient suffered pain, induration, swelling of the hand and the forearm, as well as cyanosis and bleach the fingers out." reporting due to the referenced issue; no further information regarding the patient's status 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 returned to brézins for investigation.Several tests such as pressure accuracy - occlusion alarm accuracy- accuracy flow rate measurement : were performed.All results were compliant with ifu values specifications.No functional or technical issue could be detected upon device investigation.For a better detection in case of partial occlusion (extravasation) a pressure parameters adjustment is recommended (with lower threshold and dps increase activation).Cases of extravasation (intraveinous line not in the veinous system ) can be linked to several causes such as incorrect introduction of the needle, patient movement, rupture of the vein,.However the specifications of our pumps do not outline that they should detect a wrong insertion of the iv line leading to an extremely low flowrate.This hazardous situation is outside fk responsibility regarding this kind of event which is not related to the functionality of the device.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
• 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: 16678350
• MDR Text Key: 313203476
• Report Number: 3000240707-2023-00088
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,Followup
• Report Date: 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2016
• 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
• Patient Outcome(s): Other