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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 AND WITHOUT ANTI-REGURGITATION VALVE
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B. BRAUN MEDICAL INC. HEMODIALYSIS BLOODLINES; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE Back to Search Results
Model Number SL-2010M2096
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/16/2022
Event Type  malfunction  
Event Description
B.Braun dialysis tubing set (lot # 20354001 did not prime correctly.It appeared that the venous bubble filled completely with fluid and resulted in abnormal pressure readings.Due to the pressure readings, the health care provider was unable to continue the treatment with that tubing.No harm to patient, blood returned, treatment delayed by 10 minutes due to restring of the machine.B.Braun has expedited replacement product with a different lot number.A sample has been sent for them to investigate, as we have engaged their clinical team.
 
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Brand Name
HEMODIALYSIS BLOODLINES
Type of Device
SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
824 twelfth avenue
bethlehem PA 18018
MDR Report Key15210056
MDR Text Key297707104
Report Number15210056
Device Sequence Number1
Product Code FJK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/18/2022,07/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberSL-2010M2096
Device Catalogue NumberSL-2010M2096
Device Lot Number20354001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/18/2022
Event Location Hospital
Date Report to Manufacturer08/11/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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