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

Model Number 601184

Device Problems Application Program Problem: Parameter Calculation Error (1449); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 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.

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
• Type of Device: SYSTEM/DEVICE, PHARMACY CO
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 1601 wallace drive, suite 150; carrollton, tx
• MDR Report Key: 10158502
• MDR Text Key: 196825052
• Report Number: 1641965-2020-00009
• Device Sequence Number: 1
• Product Code: NEP
• UDI-Device Identifier: 04046964957437
• UDI-Public: (01)04046964957437
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 601184
• Device Catalogue Number: 601184
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1