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

Model 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, inc.Internal report (b)(4).The complaint is under evaluation.A follow-up report will be provided after the examination results are available.
Event or Problem Description
As reported by the user facility: the patient was getting entyvio which is mixed in a bag of 250cc of saline.The infusion rate was 518 over 30 minutes.About 15 minutes into the infusion it was discovered that the rate on the pump had dropped down to 250 and it did it on its own.Patient brought it to our attention as they noticed that the pump was not running at the regular rate.There was no harm brought to the patient but this had happened before.We had to closely monitor the pump and it happened again.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The actual pump involved in the reported incident was not returned to b.Braun's carrollton, tx facility for evaluation.Logs of the pump were provided and issue reported was not confirmed from the log review investigation, however multiple tests were performed and the investigator was unable to confirmed the issue.Investigation results: the reported issue was not present during investigation.Volumetrics of 125ml/hr and 25ml tested in spec at 25.8ml or 104% of expected volume with no unexpected rate changes.Ran pump at 518ml/hr for 1.0 hour with no unexpected rate changes.Log review shows last infusion on (b)(6) 2022 and 8:55pm with an infusion start of 500ml/hr.At 9:10pm infusion was stopped with a volume infused to 120ml, rate was changed to 250ml/hr and at 10:39pm an air alarm stopped the infusion with a volume infused to 369.1ml.Perform preventive maintenance service.As a result, we were unable to determine the cause of the reported issue.All information concerning this reported incident has been included in our trend analysis of the product line.

• Brand Name: VISTAT®
• 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: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 13869102
• Report Number: 9610825-2022-00095
• Device Sequence Number: 14625572
• Product Code: FRN
• UDI-Device Identifier: 04046963988852
• UDI-Public: (01)04046963988852
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 03/31/2023

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 Model Number: 637-202
• Device Catalogue Number: 637-202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2022
• Supplement Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2021
• 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