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

Model Number	8713112D
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).The investigation into this reported event is ongoing.Additional attempts to receive the device involved in the reported event are being made.A follow-up report will be submitted when the results of the investigation are available.
Event or Problem Description
As reported by the user facility: the power cord is "scorched".
Additional Manufacturer Narrative
This report has been identified as b.Braun medical, inc.Internal report (b)(4).Further investigation of the complaint is not possible without a device for evaluation.The sample is valuable tool in investigating the cause of this incident.If the device does become available, the complaint will be reopened for further evaluation.All information concerning this reported incident has been included in our trend analysis of the product line.

• Brand Name: B. BRAUN
• 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 ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 11866075
• Report Number: 9610825-2021-00184
• Device Sequence Number: 4414713
• Product Code: FRN
• UDI-Device Identifier: 04046964085673
• UDI-Public: (01)04046964085673
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K142596
• 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): 10/03/2022

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: 8713112D
• Device Catalogue Number: 8713112D
• 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: 05/14/2021
• Supplement Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 10/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2020
• 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