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

Model Number	8713030
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/10/2024
Type of Reportable Event	Death
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.Underdose general information: complaint: (b)(4).Information to the sample: model: perfusor space article number: 8713030 serial number/batch: (b)(6) software version: 688n030005 hours of operation: 2579 further information: n/a investigation results: history inspection: the device history files were read out and analyzed.The customer specified 2024-12-10 as the date of the incident.The last therapy on this day was analyzed.2024-12-10 at 10:45 a bd plastipak 50ml was selected.The syringe was filled to approx.49ml.The drug short name morphmt was selected.The therapy was started with a flow rate of 0 ,19ml/h at 10:45.The therapy was terminated by the user after 3 hours and 37 minutes.0.73ml were infused in total.No abnormalities can be found in the device history files.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.No visible damaged parts are to locate.Functional inspection: a functional test was performed.The device passes the self-test.A bd 50 ml 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 delivery accuracy measurement according to iec 60601-2-24 was arranged.Here a nominal flow rate of 5 ml/h was chosen.The assessed mean deviation "a" of the second operating hour was measured and resulted in a value of + 0.29%.Accuracy of set delivery rate should be ± 2 % according to iec/en 60601-2-24.Disassembling: during the investigation no faults could be detected, to investigate the inside of the device, only the upper housing was removed.No damage or soiling could be found.Judgment: the complaint could not be confirmed.Summing up all tests, the perfusor space operated within our specification.No product deviation.
Event or Problem Description
According to the customer: there was an underdose - patient death.The customer has stated they do not believe the pump is at fault, they want the data history of the pump.

• 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: 21123852
• Report Number: 9610825-2024-01020
• Device Sequence Number: 8760049
• Product Code: FRN
• UDI-Device Identifier: 04046963716745
• UDI-Public: (01)04046963716745
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 01/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8713030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Male