MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PINNACLE®; FINAL ASSEMBLY - PUMP MODULE

Model Number 601184

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 01/19/2023

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical, inc.Internal report number 400586489.The investigation is ongoing at this time.A follow-up will be submitted when the investigation results become available.

Event Description

As reported by the user facility: customer reported tpn final containers were cloudy at the completion of compounding, bags were scrapped and repumped successfully.

Manufacturer Narrative

This report has been identified as b.Braun medical, inc.Internal report number (b)(4).The device was not returned for evaluation.Further investigation of the complaint is not possible without a device.If the device does become available, the complaint will be reopened for further evaluation.All information concerning this reported incident has been included in our trend analysis of the product line.

• Brand Name: PINNACLE®
• Type of Device: FINAL ASSEMBLY - PUMP MODULE
• 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: 17218762
• MDR Text Key: 318091003
• Report Number: 2523676-2023-00043
• 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: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 601184
• Device Catalogue Number: 601184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2017
• 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