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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
Catalog Number SL-2000M2095
Device Problems Device Alarm System (1012); Material Puncture/Hole (1504); Air/Gas in Device (4062)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
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: during treatment the tmp alarm was sounding off and during trouble shooting (before the system cut it off) the switched machines and changed the system.Treatment was continued.Treatment time was 180 and actual 176 minutes the same slit same shape and same length down the tubing was noted be slit.Treatment started at 6:15 and by 8:02 nurse noted the issued.No injury reported.
 
Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No samples or photos were submitted to the manufacturer for evaluation.Retained samples were evaluated and no bubbles/air in line, tubing cut or kinks were observed during the examination.A device history record (dhr) review was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.Based on the data from the investigation we are unable to determine the root cause of the reported incident.The reported defect was unable to be confirmed.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 Key17870777
MDR Text Key326007959
Report Number2521402-2023-00236
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
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/17/2024
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 Catalogue NumberSL-2000M2095
Device Lot NumberA2300263
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/13/2023
Initial Date FDA Received10/04/2023
Supplement Dates Manufacturer Received09/13/2023
Supplement Dates FDA Received04/17/2024
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 Number1
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