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

Catalog Number	8713032U
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
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 was reported due to experiencing over infusion issues.
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.Results description: investigation results: technical evaluation of the device did not identify any nonconformances or device performance problems which would directly contribute to the reported event.Volumetrics of 100ml/hr and 10ml tested in spec at 9.91ml or 99% of expected volume.Details of history log: log review shows on (b)(6) 2024 and 3:30am an infusion start of 5ml/hr and 50ml with 50ml syringe.At 3:44am a pressure alarm stopped the infusion with a volume infused to 0.58ml.At 3:52am pressure alarm stopped the infusion with volume infused to 0.60ml.At 4:02am pressure alarm stopped the infusion with volume infused to 0.64ml.At 4:11am pressure alarm stopped the infusion with volume infused to 0.65ml.At 4:19am pressure alarm stopped the infusion with volume infused to 0.65ml.At 4:30am infusion was stopped with volume infused to 1.63ml.And no further infusions taking place.

• Brand Name: PERFUSOR®
• 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: 20817627
• Report Number: 9610825-2024-00841
• Device Sequence Number: 21043640
• Product Code: FRN
• UDI-Device Identifier: 04046964797965
• UDI-Public: (01)04046964797965(11)220712(10)97034033F2
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K172831
• 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: 8713032U
• Device Lot Number: 661606
• 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: 11/07/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 01/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2022
• 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