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

Model Number	8713142U
Medical Device Problem Codes	Device Alarm System (1012); Failure to Power Up (1476); Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2023
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: cover - not functioning, blinking red light, and smoking.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The product involved in the reported incident was returned to one of our b.Braun facilities and the device was evaluated by a qualified technician during the investigation.When the pump was evaluated, the reported issue was observed.While the event reported was observed on the device, our evaluation indicated that the failure was not attributed to a b.Braun process or product failure, and that potential misuse or mishandling of the device or device components were more likely to cause the failure mode to occur.Note: customer declined repair.Device returned in unrepaired condition.

• Brand Name: B.BRAUN
• Common Device Name: PUMP, INFUSION
• 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 ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 16872568
• Report Number: 9610825-2023-00161
• Device Sequence Number: 5806092
• Product Code: FRN
• UDI-Device Identifier: 04046963716776
• UDI-Public: (01)04046963716776
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2023

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: 8713142U
• Device Catalogue Number: 8713142U
• Device Lot Number: 97035895F2
• 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: 04/13/2023
• Supplement Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 05/04/2023
• Supplement Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2022
• 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