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

Model Number 601184

Device Problem Defective Alarm (1014)

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 for signing into the compounder control panel with the default admin code.They also provided instructions for going to the options menu/settings/barcode tab to review the settings.It was found that the barcode scanning requirements had been disabled.Pinnacle support had the customer enable the requirement.The customer asked if this could be the result of their windows 10 upgrade.It was advised that the original database settings would have been carried over during the database backup/restore and upgrade process, so someone would have had to be signed on as an admin and disable to requirement.The customer asked if there is a way to look up who made the change.Pinnacle support advised the history files can be reviewed in tpn manager.The customer indicated they do not know how to review the history, however, they will have a user that knows the system take a look later.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: a technician was mixing tpn on the pinnacle machine and when changing the bags, the machine did not prompt the technician to scan the new bags.This resulted in attaching two (2) bags to the wrong tubing.The machine was set up to compound dextrose, sterile water, trophamine and travasol.The technician inadvertently hung the travasol on the dextrose tubing and the dextrose on the travasol tubing.Two (2) bags of tpn were then compounded using the travasol instead of dextrose - so there was sterile water, trophamine and travasol in the bag instead of sterile water, dextrose and trophamine.The issue was caught as the tpn bag was being administered to a baby patient.The baby patient received about 1.3ml of the tpn bag when the issue was found and the infusion was stopped.At this time no known patient medical intervention has been required.Customer stated that the safety protocol that is to be in place to force the user to the scanner the source container and station tubing barcode flag did not prevent the user error.

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 for signing into the compounder control panel with the default admin code.They also provided instructions for going to the options menu/settings/barcode tab to review the settings.It was found that the barcode scanning requirements had been disabled.Pinnacle support had the customer enable the requirement.The customer asked if this could be the result of their windows 10 upgrade.It was advised that the original database settings would have been carried over during the database backup/restore and upgrade process, so someone would have had to be signed on as an admin and disable to requirement.The customer asked if there is a way to look up who made the change.Pinnacle support advised the history files can be reviewed in tpn manager.The customer indicated they do not know how to review the history, however, they will have a user that knows the system take a look later.The device involved was not returned for evaluation.If additional pertinent information becomes available a follow-up report will be filed.

Event Description

As per reported by the user facility: a technician was mixing tpn on the pinnacle machine and when changing the bags, the machine did not prompt the technician to scan the new bags.This resulted in attaching two (2) bags to the wrong tubing.The machine was set up to compound dextrose, sterile water, trophamine and travasol.The technician inadvertently hung the travasol on the dextrose tubing and the dextrose on the travasol tubing.Two (2) bags of tpn were then compounded using the travasol instead of dextrose - so there was sterile water, trophamine and travasol in the bag instead of sterile water, dextrose and trophamine.The issue was caught as the tpn bag was being administered to a baby patient.The baby patient received about 1.3ml of the tpn bag when the issue was found and the infusion was stopped.At this time no known patient medical intervention has been required.Customer stated that the safety protocol that is to be in place to force the user to the scanner the source container and station tubing barcode flag did not prevent the user error.

• Brand Name: PINNACLE®
• Type of Device: SYSTEM/DEVICE, PHARMACY CO
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 1601 wallace drive, suite 150; carrollton TX 75006 6690
• MDR Report Key: 8619352
• MDR Text Key: 145527365
• Report Number: 1641965-2019-00011
• 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: 07/29/2019

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
• Device Operator: No Information
• Device Model Number: 601184
• Device Catalogue Number: 601184
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/06/2019
• Initial Date FDA Received: 05/17/2019
• Supplement Dates Manufacturer Received: 05/06/2019
• Supplement Dates FDA Received: 07/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1