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

Catalog Number Z021135

Device Problem No Apparent Adverse Event (3189)

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

Event Date 04/05/2023

Event Type  malfunction  

Event Description

The following has been reported: "customer reported software error code 30 during procedure/process no patient issues reported" error code 30 is defined by the techinical manual as a timekeeper issue.Reporting due to the referenced issue; no patient injuries or adverse effects were 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.Due to the reported event, device history log could not be extracted therefore no review could be performed.The reported device was received in lake zurich (il, usa) and its investigation was performed by our local technical team.Upon inspection, the reported event was confirmed as the device was blocked with a technical error 30.However it was found to be caused by a damaged/scratched cpu board likely due to usability.This complaint is considered as misuse.For this issue as per our local procedure, we initiated no action.

• Brand Name: VOLUMAT MC AGILIA US
• 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: 16839764
• MDR Text Key: 314442290
• Report Number: 3000240707-2023-00107
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121613
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: Z021135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2015
• 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