MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PINNACLE®; PINNACLE® TPN MANAGEMENT SYSTEM

Model Number	PC1000
Medical Device Problem Code	Application Program Problem: Dose Calculation Error (1189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample was returned.Device evaluation not yet completed.The investigation is ongoing at this time.A follow up will be submitted when investigation results become available.
Event or Problem Description
As reported by user facility: the pump was not pulling up solution at the beginning of compounding.No injuries were reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample was returned.Device evaluation not yet completed.The investigation is ongoing at this time.A follow up will be submitted when investigation results become available.
Event or Problem Description
As reported by user facility: the pump was not pulling up solution at the beginning of compounding.No injuries were reported.

• Brand Name: PINNACLE®
• Common Device Name: PINNACLE® TPN MANAGEMENT SYSTEM
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 1601 wallace drive; suite 150; carrollton TX 75006 6690
• Manufacturer (Section G): B BRAUN MEDICAL INC; 1601 wallace drive; suite 150; carrollton TX 75006 6690
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 14679602
• Report Number: 2523676-2022-00312
• Device Sequence Number: 20031544
• Product Code: NEP
• UDI-Device Identifier: 04046964447198
• UDI-Public: 04046964447198
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: PC1000
• Device Catalogue Number: PC1000
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/13/2022
• Supplement Report FDA Received Date: 06/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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