MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PINNACLE®; PINNACLE® TPN MANAGEMENT SYSTEM

Model Number PC1000

Device Problem Application Program Problem: Dose Calculation Error (1189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/16/2022

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).No sample was returned.Device evaluation not yet completed.The investigation is ongoing at this time.A follow up will be submitted when investigation results become available.

Event Description

As reported by user facility: the pump was not pulling up solution at the beginning of compounding.No injuries were reported.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).No sample was returned.Device evaluation not yet completed.The investigation is ongoing at this time.A follow up will be submitted when investigation results become available.

Event Description

As reported by user facility: the pump was not pulling up solution at the beginning of compounding.No injuries were reported.

• Brand Name: PINNACLE®
• Type of Device: PINNACLE® TPN MANAGEMENT SYSTEM
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 1601 wallace drive; suite 150; carrollton TX 75006 6690
• Manufacturer (Section G): B BRAUN MEDICAL INC; 1601 wallace drive; suite 150; carrollton TX 75006 6690
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 14679602
• MDR Text Key: 296973395
• Report Number: 2523676-2022-00312
• Device Sequence Number: 1
• Product Code: NEP
• UDI-Device Identifier: 04046964447198
• UDI-Public: 04046964447198
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: PC1000
• Device Catalogue Number: PC1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1