MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PINNACLE; SYSTEM/DEVICE, PHARMACY CO

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	08/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4), event 3.The device involved has not been received for evaluation and 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: event 3.There are issues with bags over-delivering on the pinnacle compounder.No injuries were reported.Final containers were scrapped.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4), event 3.The device involved was not been returned for evaluation.No additional information was provided by the customer.Per b.Braun's r&d team: - if it is happening with specific solutions, ensure the specific gravity of those solutions is set correctly in the solution database.- if it is happening with all solutions, ensure load cell and weight are not damaged or affected in any way.Troubleshooting could involve a factory reset of the load cell, ordering a new weight, etc.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: PINNACLE
• Common Device Name: SYSTEM/DEVICE, PHARMACY CO
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 1601 wallace drive, suite 150; carrollton TX 75006 6690
• MDR Report Key: 12459972
• Report Number: 2523676-2021-00305
• Device Sequence Number: 1206832
• Product Code: NEP
• UDI-Device Identifier: 04046964447198
• UDI-Public: (01)04046964447198
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2021

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: PC1000
• Device Catalogue Number: PC1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2021
• Supplement Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 09/13/2021
• Supplement Report FDA Received Date: 10/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1