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

Model Number 601184

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

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

Event Date 03/29/2022

Event Type  malfunction  

Event 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.

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.

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.

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®
• Type of Device: 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
• MDR Text Key: 289252486
• Report Number: 1641965-2022-00001
• Device Sequence Number: 1
• Product Code: NEP
• UDI-Device Identifier: 04046964957437
• UDI-Public: (01)04046964957437
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/23/2024

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?: No
• Device Operator: 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
• Initial Date Manufacturer Received: 03/29/2022
• Initial Date FDA Received: 04/14/2022
• Supplement Dates Manufacturer Received: 03/29/2022
• Supplement Dates FDA Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2012
• 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