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

Model Number	8713142U
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 incident 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 user facility: connector f4 in the back is burnt.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).Upon receipt the actual pump involved was visually and functionally inspected.Although the reported thermal damage was observed, there was evidence of fluid damage.The interface board was replaced and preventative maintenance service was performed.The device was then tested and met specifications.The instructions for use (ifu) for the space product lines states, "do not allow liquids to enter into or come into contact with any openings or electrical connections on the pump or power supply.Fluid exposure in these areas may result in the risk of short circuit, corrosion or breakdown of sensitive electrical components." the ifu also provides additional information on disinfectants and cleaning techniques that should be followed.If additional information becomes available, a follow up report will be submitted.

• 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
• MDR Report Key: 11436236
• Report Number: 9610825-2021-00061
• Device Sequence Number: 3523249
• Product Code: FRN
• UDI-Device Identifier: 04046963716776
• UDI-Public: (01)04046963716776
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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 faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2021

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1