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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN AVITUM AG DAILOG DAILYSIS MACHINE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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B. BRAUN AVITUM AG DAILOG DAILYSIS MACHINE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number SW 9.1X
Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Patient Problem Death (1802)
Event Date 08/08/2020
Event Type  Death  
Event Description
Citric acid used in place of bicarbonate. B braun dialog dialysis machine sw 9. 1x does not have built in ph meter and allowed user to continue administering dialysis without checking ph. Fda safety report id# (b)(4).
 
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Brand NameDAILOG DAILYSIS MACHINE
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
B. BRAUN AVITUM AG
MDR Report Key10448034
MDR Text Key204352725
Report NumberMW5096218
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 08/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberSW 9.1X
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

Patient Treatment Data
Date Received: 08/24/2020 Patient Sequence Number: 1
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