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

Catalog Number	637-202
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the sales representative: he reported that the customer has reported five incidents were the devices have malfunction as described.As a result, the sales representative went on site to help trouble shoot (a new nurse who had not used the pumps in the past was the initial reporter).The sales representative tested the pumps using saline and could not replicate the reported event.There were little bubbles observed as well as big bubbles observed and the pump function as intended.The sales representative pointed out that the customer did mention that they are programming the infusions to account for the bag volume and have been including the 10% overfill.The sales representative advised that they should infuse only for the correct volume and then re-run the infusion if there are residual amounts in the bag.The customer stressed that saline works fine, but it is when they use cisplatin and leucovorin that they encounter the issue.The three serial numbers were reported as (b)(6).Two of the pumps malfunctioned one time, and one of the pumps malfunctioned three times.The reported event occurred three times with the use of serial number (b)(6).This report is for event #1.Refer to manufacturer reports 9610825-2024-00805 and 9610825-2024-00806 respectively for serial number (b)(6).
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).Event 1: no sample or event logs were provided for evaluation.Based on the data from the investigation we are unable to determine the root cause of the reported incident.The reported defect was unable to be confirmed.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• 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: 20684431
• Report Number: 9610825-2024-00802
• Device Sequence Number: 8556987
• Product Code: FRN
• UDI-Device Identifier: 04046963988852
• UDI-Public: (01)04046963988852(11)160726(10)96963393F6
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/04/2025

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: 96963393F6
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2016
• 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