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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 Problem Air/Gas in Device (4062)
Patient Problem Insufficient Information (4580)
Event Date 09/07/2022
Event Type  malfunction  
Event Description
Multiple micro bubbles noted in arterial pod and dialysis circuit.Initially, arterial pressure alarm went off followed by s.A.D.Alarm.Unable to clear micro bubbles, even with pod reset.Lot # matches additional lot #s recorded for dialysis streamline tubing issues.Lot # 00554003 removed from supply.
 
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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 Key15461626
MDR Text Key300312341
Report Number15461626
Device Sequence Number1
Product Code FJK
UDI-Device Identifier04046964367786
UDI-Public04046964367786
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 09/12/2022
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 Model NumberSL-2010M2096
Device Catalogue NumberSL-2010M2096
Device Lot Number00554003
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/12/2022
Event Location Hospital
Date Report to Manufacturer09/21/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/21/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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