MAUDE Adverse Event Report: B. BRAUN MEDICAL INC PINNACLE; CONTROL PANEL

Model Number 601192

Device Problem Thermal Decomposition of Device (1071)

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

Event Type  malfunction  

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.

Event Description

As per reported by the user facility: the control panel power supply/brick caught fire and melted the power receptacle.It is unknown if there were any power surges or electrical issues within the wall outlet.It was reported the technician saw smoke and unplugged the control panel.When the power supply was removed from the control panel the technician saw flames within the power supply and the control panel.There was no patient injury.

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number 400495375.The actual control module and power brick involved in the reported incident were returned for evaluation.When the items were evaluated the reported issue was observed.The root cause of the thermal damage could not be determined.The pinnacle tpn management system and its components (which includes the power supply/power brick) have been thoroughly tested for protection against fire.The system components conform to electrical safety standard iec 61010-1 clause 9 for protection against the spread of fire, which includes compliance for containment of fire within the equipment, should it occur.The power supply as a sub-component is also compliant with ul requirements for protection against fire.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: PINNACLE
• Type of Device: CONTROL PANEL
• Manufacturer (Section D): B. BRAUN MEDICAL INC; 1601 wallace drive, suite 150; carrollton TX 75006 6690
• MDR Report Key: 10965674
• MDR Text Key: 220124211
• Report Number: 1641965-2020-00023
• Device Sequence Number: 1
• Product Code: NEP
• UDI-Device Identifier: 04046964957444
• UDI-Public: (01)04046964957444
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/26/2021

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 Operator: Health Professional
• Device Model Number: 601192
• Device Catalogue Number: 601192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Initial Date Manufacturer Received: 11/23/2020
• Initial Date FDA Received: 12/08/2020
• Supplement Dates Manufacturer Received: 11/23/2020
• Supplement Dates FDA Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1