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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. STREAMLINE BLOODLINE SET FOR DIALOG+ HEMODIALYSIS SYSTEM; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
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B. BRAUN MEDICAL INC. STREAMLINE BLOODLINE SET FOR DIALOG+ HEMODIALYSIS SYSTEM; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE Back to Search Results
Model Number SL-2010M2096
Device Problems Device Alarm System (1012); Protective Measures Problem (3015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/29/2022
Event Type  malfunction  
Event Description
Machine alarm s.A.D.10 minutes after starting patient on dialysis.Tubing, machine and connects all looked over without any obvious cause for alarm.Staff was unable to clear or reset alarm and machine became "stuck" in s.A.D.Alarm mode.Staff had to hand crank machine to return pt blood.Patient remained unharmed though.Machine was then restrung with new lines.This particular incident, with machine becoming stuck in s.A.D.Alarm mode has happened three times in the unit today using lines from the same lot number.
 
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Brand Name
STREAMLINE BLOODLINE SET FOR DIALOG+ HEMODIALYSIS SYSTEM
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 Key15713747
MDR Text Key302838084
Report Number15713747
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 10/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSL-2010M2096
Device Catalogue NumberSL-2010M2096
Device Lot Number20754002
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/31/2022
Event Location Outpatient Treatment Facility
Date Report to Manufacturer11/02/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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