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

Catalog Number	8713051U
Medical Device Problem Codes	Device Alarm System (1012); Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
As reported by the user facility: patient was scheduled to receive magnesium ivpb.After the primary rn initiated the infusion and while still present in the room, she observed that the pump had bolused the patient.The iv bag was nearly empty, and the clamp was in place.The patient remained stable.The pump and iv tubing have been sequestered.Please advise on the next steps regarding the pump and iv tubing." according to integration interface messages, the nurse encountered a 10005 timeout error when attempting to auto-program magnesium as a secondary on pump 807962, so manual programming possible.Pump and iv tubing sequestered in sfh biomed department.
Additional Manufacturer Narrative
This complaint has been identified as b braun medical internal complaint number (b)(4).The actual device involved in the reported incident was returned for evaluation.When the device was evaluated the reported issue was not observed.Technical evaluation of the device did not identify any nonconformance's or device performance problems which would directly contribute to the reported event.The logs were provided for review.Log review shows on (b)(6) 2025 and 6:26am a primary rate of 75ml/hr and a piggyback infusion start of 50ml/hr and 50ml (dl: mag 2).At 6:27am infusion was stopped with a volume infused to 0.88ml and at 6:30am door was opened.Preventative maintenance was performed.All information concerning this reported incident has been included in our trend analysis of the product line.

• Brand Name: INFUSOMAT®
• 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 ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 22120504
• Report Number: 9610825-2025-00312
• Device Sequence Number: 14480629
• Product Code: FRN
• UDI-Device Identifier: 04046964708626
• UDI-Public: (01)04046964708626(11)211103(10)97023424I1
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K142596
• 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): 07/02/2025

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: 8713051U
• Device Lot Number: 97023424I1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/31/2025
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2021
• 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