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

Model Number	8713030
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	12/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the event description: a nurse prepared an ops with potassium and confirmed that during the procedure, it was reported that the syringe infused 20 ml of potassium while "approaching." as a result, the patient required resuscitation.During the next shift, the patient was resuscitated again due to respiratory acidosis.Invasive ventilation.Additional information was received from the customer facility: "regarding the patient, i regret to inform you that the patient has passed away.According to the department, this has nothing to do with the incident involving the perfusor.".
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.General information: complaint: (b)(4).Information to the sample: model: perfusor space, article number: 8713030, serial number/batch: (b)(6), software version: n030005, hours of operation: 9590, further information: n/a.Investigation results: history inspection: the device history files were read and analyzed.The device history files from (b)(6) 2025 were investigated.No abnormalities were found.Visual inspection: a visual inspection was performed.The cover caps on the screw pillars, and the production seal on the lower housing were intact and undamaged.The device is in a clean state and it could be found a slightly bent tube of the drive head.Functional inspection: a functional test was performed.The device passes the self test.A ops 50ml syringe was inserted, and the pump identified the syringe and it could be selected from the menu.It was possible to put the pump in operation.Individual inspection: a syringe change was performed, several times.During the functional test, the malfunction could not be reproduced.Disassembling: the device was disassembled, and the inside was investigated.It could be found a slightly bent tube of the drive head.No other visible damage was found.Judgment: the complaint could not be confirmed.Summing up all tests, the perfusor space operated within our specification.No product deviation.Addition information: it could not be excluded, that the malfunction occurred because of the bent tube of the drive head.

• Brand Name: PERFUSOR®
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): B BRAUN MELSUNGEN AG; carl-braun str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B BRAUN MELSUNGEN AG; carl-braun str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 21354305
• Report Number: 9610825-2025-00023
• Device Sequence Number: 15735091
• Product Code: FRN
• UDI-Device Identifier: 04046963716745
• UDI-Public: (01)04046963716745(10)96996687A0
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/11/2025

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 Model Number: 8713030
• Device Lot Number: 96996687A0
• 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: 01/15/2025
• Initial Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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