MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PINNACLE®; COMPOUNDER

Model Number 601184

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

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

Event Date 03/01/2023

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical, inc.Internal report number (b)(4).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: pump dispensing dextrose while volume set to zero.

Manufacturer Narrative

This report has been identified as b.Braun medical, inc.Internal report number (b)(4).The actual device involved in the reported incident was returned to b.Braun medical in carrollton, tx 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: pump dispensing dextrose while volume set to zero.

• Brand Name: PINNACLE®
• Type of Device: COMPOUNDER
• 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: 16640337
• MDR Text Key: 312491336
• Report Number: 2523676-2023-00078
• 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: 03/29/2023
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2012
• 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