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

Catalog Number	637-202
Medical Device Problem Codes	False Alarm (1013); Failure to Charge (1085); Failure to Pump (1502)
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: these are the issues with the 3 pumps being reported: serial nr#'s (b)(6).Pumps do not hold a charge despite being plugged in overnight continuously say 'occlusion' or 'air in line' despite neither of which really present.When pressing start for infusion, frequently will flash from several different screens randomly and suddenly not work.Need to turn off and back on and reset.Sometimes will just not infuse despite everything being correct.Need to turn off and on several times before it either starts working or need to just not use pump and run by gravity.Pump sn: (b)(6) - mdr#: 9610825-2025-00680, pump sn: (b)(6) - mdr#: 9610825-2025-00681.
Additional Manufacturer Narrative
This complaint has been identified as b braun medical internal complaint number (b)(4).The device was not returned for evaluation.Further investigation of the complaint is not possible without a device for evaluation.If the device does become available, the complaint will be reopened for further evaluation.All information concerning this reported incident has been included in our trend analysis of the product line.

• Brand Name: VISTA®
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen 34212 ; GM 34212
• Manufacturer Contact: elena reifenstein ; 824 12th avenue; bethlehem, PA 18018 ; 4847197287
• MDR Report Key: 23658857
• Report Number: 9610825-2025-00682
• Device Sequence Number: 18648662
• Product Code: FRN
• UDI-Device Identifier: 04046963988852
• UDI-Public: (01)04046963988852(11)050902
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 12/05/2025

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
• Device Lot Number: N/A
• 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: 10/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2005
• 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