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

Model Number	8713050
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2025
Type of Reportable Event	Malfunction
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.With the batch number 24k16a8701 were produce (b)(4) sets for order no.(b)(4).General information: complaint: (b)(4).Information to the sample: model: infusomat space, article number: 8713050, serial number/batch: (b)(6), software version: m030003, hours of operation: 24173, 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.A space line safeset was selected and the infusion started with a rate of 190ml/h at 01:13am.30 minutes later, at 01:43am the infusion was change to 260ml/h.At 02:36am the upstream alarm occurred and the infusion stopped.At this time, 322,41ml was infused.No other 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 no visible damage are to locate.Functional inspection: a functional test was performed.The device passes the self-test.A space line was inserted, and the pump identified the line, and it could be selected from the menu.It was possible to put the pump in operation.Pressure inspection: in checking the downstream-sensor the electronic pressure cut-off and the mechanical pressure limitation of the device were tested, according to the requirements of the technical safety check.The device matches the required values and standards.All measured values are within our specification.Flow rate inspection: a delivery accuracy measurement according to iec 60601-2-24 was arranged.Here a nominal flow rate of 100 ml/h was chosen.The assessed average deviation "a" of the second operating hour was measured and resulted in a value of -0,78%.((accuracy of set delivery rate should be: ± 5 % according to iec/en 60601-2-24) the device matches the required values and standards.All measured values are within our specification.Disassembling: the device was disassembled, and the inside was investigated.Inside the device was slightly dirty but no visible damage was found inside the device.Judgment: the complaint could not be confirmed.Summing up all tests, the infusomat space operates within our specification.No product deviation.
Event or Problem Description
According to the event description: short infusion of 190 ml/h programmed without target volume.The medication had a total volume of 90 milliliters (ml) (incl.Rinsing volume with one time bottle).Normally the first infusion bottle should be should be empty after about 20 minutes so that 10 minutes remain for rinsing.After more than 30 minutes, i noticed that the first bottle (65 milliliters (ml)) was still still not inside.Infusion rate increased to 260 milliliters an hour (ml/h).The second infusion bottle with 30ml should have been ready in 7 minutes with a run rate of 260 milliliters an hour (ml/h) should have been ready in 7 minutes.However, the infusomat needed 20 minutes for this.Afterwards, using the same infusion set and a new infusion bottle infusion bottle (not on the patient).Set a flow rate of 20 milliliters an hour (ml/h) and stopped after 30minutes.Instead of the 10 milliliters (ml) there were only 5 milliliters (ml).Possible serious consequences: shelf life / stability of the drug has been exceeded.

• Brand Name: INFUSOMAT®
• 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: 21409771
• Report Number: 9610825-2025-00031
• Device Sequence Number: 21168339
• Product Code: FRN
• UDI-Device Identifier: 04046963716752
• UDI-Public: (01)04046963716752(11)190321(10)96983665C9
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 02/19/2025

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: 8713050
• Device Lot Number: 96983665C9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Age: 4 YR
• Patient Sex: Unknown