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	07/30/2021
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: patients reported to customer that bags are running dry during infusion.The bags are compounded on the pinnacle compounder.User facility has tried increasing overfill and calibrating the pump after every bag.They report that no pinnacle errors have occurred during this time.No injuries were reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The device involved has was not returned for evaluation.The customer did provide compounding reports but it was not indicated which order specifically ran dry.B.Braun engineering reviewed the reports.They are recommending that the customer should be programming the "with overfill" volume in the compounder.If they are not, that could be the main reason for bags running dry but it is not clear from the information provided if that is what the customer is doing.It is also recommended that the load cell is calibrated correctly with a correct 1kg mass and all the solutions in their database have the correct specific gravity.Based on the results of this investigation, no specific conclusions can be made regarding the cause of the reported event.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: 12306368
• Report Number: 2523676-2021-00253
• Device Sequence Number: 17064371
• Product Code: NEP
• UDI-Device Identifier: 04046964447198
• UDI-Public: (01)04046964447198
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 09/29/2021

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: 07/30/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 08/11/2021
• Supplement Report FDA Received Date: 09/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1