MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. HEMODIALYSIS BLOODLINES; SET, TUBING, BLOOD, WITH A

Catalog Number	SL-2000M2095L
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: brief inquiry description microbubbles appear in tubing while running detailed inquiry description microbubbles are noted in arterial tubing after tx has been going for 2-3 hrs.Sometimes, they change the extracorporeal circuit to finish out the tx.Did not specify the frequency but stated it varies.Instructed staff on the correct procedure for connecting patient-end of bloodline (making sure connection is 'tight' prior to twisting red disconnect preventer collar) and also instructed on prograde rinseback technique so that all blood passes through air detector during the rinseback (for safety).
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow-up will be submitted when the investigation results become available.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The device history record of manufactured lot a2400115 was reviewed issues were not reported during production.A visual examination of the photograph was performed and it was noted that the photograph depicts the partial end of the set and small microbubbles were visible in line during time use indicated by the set being filled with blood when the photo was captured.Unfortunately, without a physical sample to properly perform an evaluation, it was quite difficult to determine the cause of air entering the line.Based on the results of testing performed on the photograph returned the reported defect of air in line was confirmed.Corrective actions include retraining of personnel with a visual aid to create awareness into the process.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: HEMODIALYSIS BLOODLINES
• Common Device Name: SET, TUBING, BLOOD, WITH A
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 824 12th avenue; bethlehem PA 18018
• Manufacturer (Section G): B. BRAUN MEDICAL INC.; 824 12th avenue; bethlehem PA 18018
• Manufacturer Contact: jonathan severino ; 901 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 19625994
• Report Number: 2521402-2024-00063
• Device Sequence Number: 8121300
• Product Code: FJK
• UDI-Device Identifier: 04046955348909
• UDI-Public: (01)04046955348909
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K080807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: SL-2000M2095L
• Device Lot Number: A2400115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown