MAUDE Adverse Event Report: B. BRAUN AVITUM AG VISTA®; PUMP, INFUSION

Catalog Number	637-202
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
Event or Problem Description
As reported by the user facility: according to the complainant, the infusion volume programmed in vista basic does not correspond with the actual volume delivered; for instance, if it is set to deliver 500 milliliters (ml), it may only infuse 400ml.This happened to several of our patients (their ivig is ordered to run over a range of time, usually 2-4 hours, and this resulted in a slight delay.This was adjusted by adding time to the pumps and the infusion was able to run without further issue, but not at the time that was initially programmed/intended).Reference mdr id 9610825-2025-00064 and 9610825-2025-00065 for other associated events.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Test result(s): [ ] defect confirmed [x] defect not confirmed - due to no sample reported issue could be not b confirmed.

• Brand Name: VISTA®
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): B. BRAUN AVITUM AG; schwarzenberger weg 73-79; melsungen, 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN AVITUM AG; schwarzenberger weg 73-79; melsungen, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 21349363
• Report Number: 9610825-2025-00051
• Device Sequence Number: 18411759
• Product Code: FRN
• UDI-Device Identifier: 04046963988852
• UDI-Public: (01)04046963988852
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K003029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 637-202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 03/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown