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

Model Number	8713030U
Medical Device Problem Codes	Device Alarm System (1012); Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
Event or Problem Description
As reported by the user facility: pump had delay in stopping for an occlusion at low flow rate.Connected to trifuse with caresite.Fluid backed up into syringe.Iv line was connected to a trifuse that had a caresite connected instead of nexus tko low flow rate was 0.5 for the carrier fluid and there was also a med line going at.04ml/hr.Pressure setting default 6, rn unsure if it had been adjusted.The pump had a delay to alarm occlusion even for the two hours that the line was clamped.There were no issues with medication administering when at higher rates.Rn noticed 2ml backed up into the syringe from precedex that was going at 0.04ml/hr.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The pump involved in the reported incident was never returned to any of our b.Braun facilities for investigation or evaluation therefore the issue reported could not be confirmed.Further investigation of the complaint was not possible without a sample.Therefore issues reported could not be confirmed.

• Brand Name: PERFUSOR®
• Common Device Name: PUMP, INFUSION, PCA
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd; allentown, PA 18109 ; 4047197287
• MDR Report Key: 15958027
• Report Number: 9610825-2022-00509
• Device Sequence Number: 20215190
• Product Code: MEA
• UDI-Device Identifier: 04046963716745
• UDI-Public: (01)04046963716745
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K092313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2023

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: 8713030U
• Device Catalogue Number: 8713030U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2022
• Supplement Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (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 Sex: Unknown