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

Catalog Number 601184

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 02/20/2024

Event Type  malfunction  

Manufacturer Narrative

Thie report has been identified as b.Braun medical, inc.Internal report (b)(4).The actual device involved in the reported incident was returned for evaluation.When the device was evaluated the reported issue was not observed.The device operated as intended.Preventative maintenance was performed.

Event Description

As reported by the user facility: lipids backflowing into transfer set.

• 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; GM 750066690
• Manufacturer (Section G): B. BRAUN MEDICAL INC.; 1601 wallace drive; suite 150; carollton, tx 75006 6690; GM 750066690
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 19051224
• MDR Text Key: 339490387
• Report Number: 2523676-2024-00265
• 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
• Report Date: 04/05/2024

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 Catalogue Number: 601184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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