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

Catalog Number	SL-2000M2095
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/27/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
As reported by the user facility: event 7 brief inquiry description air in line detailed inquiry description while treatment was in progress, the nurses noticed air bubbles in the arterial line, as well as significant amount of air in the venous chamber, which triggered "air detector" alarm.The amount of air was significant enough that the alarm could not be cleared by the normal troubleshooting steps ( decrease bfr, pull air from the venous chamber with a syringe, etc.).They had to remove the defective lines and set up a new system to continue the treatment.Over the last few days, they had 8 instances when they were unable to return blood.Approximate blood loss/patient -250 ml.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Event 7.One (1) sample was submitted to the manufacturer for evaluation.Through visual examination, no defects or abnormalities were observed.The sample was then leak tested; no leakages were observed.The bonded area and any potential cuts in the tubing, which might permit air ingress, were examined with particular care.However, no leaks or cuts were detected during the exhaustive visual inspection of the sample.The sample is within specification; the reported defect is not confirmed.A review of the device history record (dhr) was performed for the reported lot number and no abnormalities or nonconformance's were noted during the in process or final product inspection.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: 20453546
• Report Number: 2521402-2024-00120
• Device Sequence Number: 9232218
• Product Code: FJK
• UDI-Device Identifier: 04046964367762
• UDI-Public: (01)04046964367762
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 11/22/2024

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-2000M2095
• Device Lot Number: A2400385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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