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

Catalog Number	637-202
Medical Device Problem Codes	Failure to Charge (1085); Excess Flow or Over-Infusion (1311); Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: unit reported to be causing inaccurate infusion rates and needing a battery replacement.
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.
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.Investigation results: technical evaluation of the device did not identify any nonconformances or device performance problems which would directly contribute to the reported event.Delivery accuracy tested good.Perform preventive maintenance service including replacing battery.

• 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: 20577398
• Report Number: 9610825-2024-00808
• Device Sequence Number: 8170500
• Product Code: FRN
• UDI-Device Identifier: 04046963988852
• UDI-Public: (01)04046963988852(11)140313(10)96950742K3
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 01/18/2025

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: 96950742K3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 01/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2024
• 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