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

Catalog Number	8713031U
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
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: technical evaluation of the device did not identify any nonconformances or device performance problems which would directly contribute to the reported event.Volumetric accuracy tested in spec.Igation results become available.Active device history log review: [ ] n/a [ ] defect confirmed [x] defect not confirmed.Details of history log: log review shows on (b)(6) 2026 and 6:44am a dose over time infusion set-up of 9.51 ml/hr and 6 hours (dl: kphosph; total dose.166 mmol; patient weight 20kg), followed by new total dose set to 3.312 mmol (189.8 ml/hr) and at 6:46pm an infusion start.At 6:48pm with volume of 6.59 ml pressure alarmed, then at 6:50pm an infusion start.At 7:00pm syringe near empty alarmed and at 7:02pm infusion was stopped with volume infused to 44.93 ml.
Event or Problem Description
As reported by the user facility: syringe is involved in an incident for infused too fast.

• 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: elena reifenstein ; 901 marcon blvd.; allentown, PA 18109 ; 8334251464
• MDR Report Key: 24561398
• Report Number: 9610825-2026-00111
• Device Sequence Number: 8828943
• Product Code: FRN
• UDI-Device Identifier: 04046964797958
• UDI-Public: (01)04046964797958(11)230523(10)97049903D3
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 03/10/2026

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: 8713031U
• Device Lot Number: 97049903D3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2023
• 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