MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. INFUSOMAT®; SET, ADMINISTRATION, INTRA

Catalog Number 480264

Device Problem Air/Gas in Device (4062)

Patient Problem Needle Stick/Puncture (2462)

Event Date 02/13/2024

Event Type  malfunction  

Event Description

As reported by the user facility: brief inquiry description: ail secondary set.Detailed inquiry description: cbdc: bedside rn circle primed hazardous mmf and programmed it to run over two hours.30 minutes into infusion pump reported air in line.Air in line amount was almost the entire length of the tubing that is placed into the pump (>4 inches).Bedside rn then had to disconnect from primary tubing and circle prime medication again, resulting in additional cvl access.This is a significant amount of air to be allowed into tubing even with correct circle priming technique and a significant amount of air required prior to pump alarming air in line.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number: (b)(4).No sample and/or lot number were provided.Further investigation of the complaint is not possible without a sample and or lot number.The actual defective device is valuable tool in investigating the cause of this incident.Because a lot number was not provided it is not possible to determine if this device met the specifications that applied at the time it was manufactured.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: INFUSOMAT®
• Type of Device: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer (Section G): B. BRAUN DOMINICIAN REPULIC INC.; las americas industrial park; km22 autopista las americas; santo domingo, ; DR
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 18839637
• MDR Text Key: 337547775
• Report Number: 2523676-2024-00250
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 04046955778744
• UDI-Public: (01)04046955778744
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 480264
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1