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

Model Number	601184
Medical Device Problem Codes	Application Program Problem: Parameter Calculation Error (1449); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).The b.Braun pinnacle support technician provided instructions to perform the factory calibration.Customer was advised that under no circumstances should any user ever circumvent the calibration process as this places patient safety at risk.After performing the factory calibration the 1000 gram calibration weight read 1000 grams on the load cell.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 per reported by the user facility: customer reported the 1000 gram weight measured 983 grams during calibration.They placed additional weights on the load cell until the calibration read the scale at 1 kilogram.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).The b.Braun pinnacle support technician provided instructions to perform the factory calibration.Customer was advised that under no circumstances should any user ever circumvent the calibration process as this places patient safety at risk.After performing the factory calibration the 1000 gram calibration weight read 1000 grams on the load cell.The device involved was not returned for evaluation.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
• MDR Report Key: 10158502
• Report Number: 1641965-2020-00009
• Device Sequence Number: 11729146
• Product Code: NEP
• UDI-Device Identifier: 04046964957437
• UDI-Public: (01)04046964957437
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2020

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: No Information
• Device Model Number: 601184
• Device Catalogue Number: 601184
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 05/20/2020
• Initial Report FDA Received Date: 06/16/2020
• Supplement Report FDA Received Date: 08/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1