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	09/02/2024
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: syringe of fentanyl 500mcg/10ml placed on 2.9 at 6pm.Programmed flow rate: 20 mcg/h.On 3.9 at 8am, empty syringe.Estimated duration was 25 hours (without bolus).Mr did not receive a bolus during the entire treatment.According to the icls + icus, preparation of the product complies with the it.
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.Corrected information: d4 primary unique device identifier (udi) number.Additional information: d9: device returned to manufacturer.H4: device manufacturer date.General information: complaint: (b)(4).Information to the sample: model: perfusor space, article number: (b)(4), serial number/batch: (b)(6), software version: n030004, hours of operation: 20999, further information: n/a.Investigation results: history inspection: the device history files were read and analyzed.The device history files from on (b)(6) 2024 were investigated.On (b)(6) 2024, at 18.01pm a omnifix 50ml syringe was selected.The syringe was filled too approx.7ml.The infusion started with a rate of 0,4ml/h and a volume of 10ml at 18:02pm.During the infusion, three times a bolus of 0,4ml was selected.On (b)(6) 2024 at 08:41am the syringe was empty, and the infusion stopped.At this time, 6,95ml was infused.No other abnormalities were found.The syringe was extracted.Visual inspection: a visual inspection was performed.The cover caps on the screw pillars, and the technician seal (41-01-210) on the lower housing were intact and undamaged.The device shows age related signs of wear and tear and a damage on the p2-connector were found.Functional inspection: a functional test was performed.The device passes the self-test.A 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 +0,66%.Accuracy of set delivery rate should be ± 2 % according to iec/en 60601-2-24.Disassembling: the device was disassembled and the inside was investigated.No other damages could be found inside the device.Judgment: the complaint could not be confirmed.Summing up all tests, the perfusor space operated within our specification.No product deviation.The damage parts are damaged by an impact damage.

• 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: 20415720
• Report Number: 9610825-2024-00765
• Device Sequence Number: 12862131
• Product Code: FRN
• UDI-Device Identifier: 04046963716745
• UDI-Public: (01)04046963716745(17)130319(10)5059906033
• 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,Followup
• Report Date (Section B): 11/25/2024

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 Model Number: 8713030
• Device Lot Number: 5059906033
• 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: 09/11/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2013
• 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: Male