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
Event or Problem Description
According to the event description: syringe of fentanyl 500mcg/10ml placed on 2.9 at 3:30 p.M.Programmed flow rate: 20 mcg/h.On 3.9 at 8 a.M., empty syringe.Estimated duration was 25 hours (without bolus).Mme received only 1 bolus of 0.4 ml at 7 p.M.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).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).Updated information: d9 device returned to manufacturer.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: 8713030; serial number/batch: (b)(6); software version: n030004; hours of operation: 23131; further information: n/a.Investigation results: history inspection: the device history files were read and analyzed.The device history files from (b)(6) 2024 were analyzed.A omnifix 50ml syringe was inserted and the infusion started with a rate of 0,4ml/h and a volume of 10ml at 14:53 pm.During the infusion, the bolus was started, two times.On the next day at 07:01 the syringe was empty and the infusion stopped.At this time, 7,3ml was infused.No other abnormalities were found.Visual inspection: a visual inspection was performed.The cover caps on the screw pillars, and the 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 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 +0,75%.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 orsoiling 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: 20415751
• Report Number: 9610825-2024-00764
• Device Sequence Number: 18242972
• Product Code: FRN
• UDI-Device Identifier: 04046963716745
• UDI-Public: (01)04046963716745(11)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): 11/14/2024

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: 11/14/2024
• 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