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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDISYSTEMS / B. BRAUN MEDICAL INC. STREAMLINE AIRLESS SYSTEM FOR B BRAUN DIALOG MACHINES DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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MEDISYSTEMS / B. BRAUN MEDICAL INC. STREAMLINE AIRLESS SYSTEM FOR B BRAUN DIALOG MACHINES DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Lot Number 90354018
Device Problems Component Missing (2306); Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/12/2019
Event Type  malfunction  
Event Description
Defective hemodialysis bloodlines. The arterial line is missing the hub to connect the arterial transducer. Fda safety report id# (b)(4).
 
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Brand NameSTREAMLINE AIRLESS SYSTEM FOR B BRAUN DIALOG MACHINES
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
MEDISYSTEMS / B. BRAUN MEDICAL INC.
MDR Report Key9504256
MDR Text Key172576953
Report NumberMW5091782
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number90354018
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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