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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the event description: the pump administered a large dose of morphine in a very short time.Programmed to administer 30 milligrams (mg) of morphine over 24 hours in a volume of 24 milliliters (ml), at a speed of 1 milliliter an hour (ml/h), it administered 13 milliliters (ml) in 1 hour 30 minutes, or 16.25 milligrams (mg) of morphine.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).A follow-up report will be provided after the examination results are available.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.
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: (b)(4), serial number/batch: (b)(6), software version: 688j030003, operating hours: 36017, further information: n/a.Investigation results: history inspection: the device history files were read out and analyzed.The customer specified on (b)(6) 2025 as the date of the incident.On (b)(6) 2025 at 8:21 a b.Braun omnifix 50ml syringe was selected.Vtbi was set to 24ml.The therapy was started with a flow rate of 1ml/h at 7:00.During the therapy, 8 manual boluses were performed.After 22 hours and 2 minutes the therapy was terminated by syringe empty alarm (on (b)(6) 2025).23.67ml 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.The device is heavily soiled with liquid.The ribbon cable from the control unit is very kinked so that the control unit cannot be opened completely to the front.It is difficult to insert a syringe like this.Functional inspection: a functional test was performed.The device passes the self-test.A bbraun omnifix 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 +0.21%.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.The ribbon cable from the control unit is very kinked so that the control unit cannot be opened completely to the front.It is difficult to insert a syringe like this.Addition information: it is recommended to replace the control unit and the p2 plug.

• 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: 21363188
• Report Number: 9610825-2025-00027
• Device Sequence Number: 8438374
• Product Code: FRN
• UDI-Device Identifier: 04046963716745
• UDI-Public: (01)04046963716745
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 04/08/2025

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 04/08/2025
• 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
• Patient Sex: Unknown