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

Catalog Number	8713030
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Type of Reportable Event	Malfunction
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.
Event or Problem Description
According to the event description: a patient was being sedated for work up and the sedation involved using a propofol cri.The cri was connected to the patient and programmed to give a 2mg/kg bolus dose.However, the dose the patient received was nearly a 10x overdose.As far the anesthetist in charge of the case can see, the patient details, weight 11 kilograms (kg) , infusion rate 0.1 milligrams per kilograms per minute (mg/kg/minute) and concentration 10 milligrams per milliliter (mg/ml) were all programmed correctly.We are unsure if the bolus was accidentally programmed to deliver 20 milligrams per kilograms (mg/kg) instead of 2 milligrams per kilograms (mg/kg) or if the syringe driver genuinely malfunctioned.
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.Over infusion general information: complaint: (b)(4).Information to the sample: model: perfusor space article number: 8713030 serial number/batch: 674514 software version: n030005 hours of operation: 808 further information: n/a investigation results: history inspection: the device history files were read and analyzed.The device history files from 2024-10-29 were analyzed.A bd plastipak 20ml syringe was selected and the infusion started with a rate of 6,78ml/h and a volume of 17ml.After the infusion started, a bolus of 22,6ml with a rate of 568,9ml/h was started.After 2 minutes the infusion stopped, because the volume of 17ml was reached.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 damaged parts are to locate.Functional inspection: a functional test was performed.The device passes the self-test.A bd plastipak 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 +0,69%.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.

• 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: 20792602
• Report Number: 9610825-2024-00854
• Device Sequence Number: 20785762
• Product Code: FRN
• UDI-Device Identifier: 04046963716745
• UDI-Public: (01)04046963716745(11)200615
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2024

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: 8713030
• 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: 10/30/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2020
• 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