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

Model Number	601184
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	03/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: customer called to report an intermittent issue with the pump dispensing lipids into orders that do not have lipids ordered.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical, inc.Internal report number (b)(4).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.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical, inc.Internal report number (b)(4).The device was returned for investigation.Investigation results: the reported issue was not present during investigation.9 station volumetric's tested in spec without alarms.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical, inc.Internal report number (b)(4).A correction report is being filed in order to change report section b1.The previous reports were incorrectly filed as "adverse event" but should have been fied as "product problem".

• Brand Name: PINNACLE®
• Common Device Name: SYSTEM/DEVICE, PHARMACY CO
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 1601 wallace drive; suite 150; carollton TX 75006 6690
• Manufacturer (Section G): B. BRAUN MEDICAL INC.; 1601 wallace drive; suite 150; carollton TX 75006 6690
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 14110832
• Report Number: 1641965-2022-00001
• Device Sequence Number: 12369163
• Product Code: NEP
• UDI-Device Identifier: 04046964957437
• UDI-Public: (01)04046964957437
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 601184
• Device Catalogue Number: 601184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2022
• Supplement Date Received by Manufacturer: 03/29/2022; Not provided
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 01/23/2024; 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown