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
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Condition of returned samples - sample status: [x] no sample returned [ ] sample returned test result(s): [ ] defect confirmed [x] defect not confirmed - results description: no sample.
Event or Problem Description
Vista basic pump did not alarm for air that went past pump to patient, on a couple of occasions infusing cisplatin and leucovorin the pump did not alarm for air almost reaching the patient.The three serial numbers were reported as (b)(6) (3 events).Two of the pumps malfunctioned one time, and one of the pumps malfunctioned three times.This report is for serial number (b)(6).Refer to manufacturer report 9610825-2024-00805 for serial number (b)(6).Refer to manufacturer reports 9610825-2024-00802 (b)(6) and for the three events involving serial number (b)(6).

• 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: 20683990
• Report Number: 9610825-2024-00806
• Device Sequence Number: 7262678
• Product Code: FRN
• UDI-Device Identifier: 04046963988852
• UDI-Public: (01)04046963988852(11)141218(10)96954148I4
• 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
• Report Date (Section B): 11/14/2024

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: 96956313C5
• 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
• Initial Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2015
• 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