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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 Air/Gas in Device (4062)
Patient Problem Insufficient Information (4580)
Event Date 07/22/2022
Event Type  malfunction  
Event Description
Health care provider had set up the machine and strung the lines.Once it was indicated to connect disposable to recirculation, health care provider connected the lines and went to release the air form the venous chamber but it would not release by opening the valve like it should.Health care provider tried to pull the air out with a syringe but once it was released it filled with air again.Health care provider tried to connect the couplings, while the blue was disconnected it filled with water but filled with air again as soon as the blue coupling was connected.All machine tests ran successfully but the chamber was still full of air.After discussing the problem with management we decided to take down the machine.The system passed all tests to start treatment but the chamber was still full of air.We pulled the lines and saved them to be checked for defects.Lot # a2200267.
 
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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 Key15327079
MDR Text Key298970697
Report Number15327079
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 08/15/2022
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 NumberA2200267
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/25/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/15/2022
Event Location Hospital
Date Report to Manufacturer08/31/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/31/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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