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U.S. Department of Health and Human Services

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

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B. BRAUN MEDICAL INC. HEMODIALYSIS BLOODLINES; SET, TUBING, BLOOD, WITH A Back to Search Results
Model Number SL-2000M2095
Device Problem Air/Gas in Device (4062)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/01/2023
Event Type  malfunction  
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 Description
As reported by the user facility: event 1: detailed inquiry description: the saline line that comes with the blood tubing was not pulling saline but air.When the treatment is complete, the arterial line is placed on the port on the saline line which then slowly returns the patient's blood out of the dialysis line circut.No injury reported.
 
Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Event 1 five (5) photographs were submitted to the manufacturer for evaluation.Through visual examination, it was noted the arterial and venous lines were being used on the dialysis machine.It was difficult to determine an air in line defect with the photographs provided.Based on the investigation, the reported defect could not be observed.A review of the device history record (dhr) was performed for the reported lot number and no abnormalities or non-conformances 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.
 
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Brand Name
HEMODIALYSIS BLOODLINES
Type of Device
SET, TUBING, BLOOD, WITH A
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
824 12th avenue
bethelehem PA 18018
Manufacturer (Section G)
B. BRAUN MEDICAL INC.
824 12th avenue
bethelehem PA 18018
Manufacturer Contact
jonathan severino
901 marcon blvd.
allentown, PA 18109
4847197287
MDR Report Key17161792
MDR Text Key317673790
Report Number2521402-2023-00183
Device Sequence Number1
Product Code FJK
UDI-Device Identifier04046964367762
UDI-Public(01)04046964367762
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080807
Number of Events Reported1
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,Followup
Report Date 06/13/2024
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
Device Operator Health Professional
Device Model NumberSL-2000M2095
Device Catalogue NumberSL-2000M2095
Device Lot NumberA2300030
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/01/2023
Initial Date FDA Received06/20/2023
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/13/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/07/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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