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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN AVITUM AG - MELSUNGEN DIALOG+ DIALYZER, HIGH PERMEABILIT

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B. BRAUN AVITUM AG - MELSUNGEN DIALOG+ DIALYZER, HIGH PERMEABILIT Back to Search Results
Catalog Number 710500L
Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Insufficient Information (4580)
Event Date 08/08/2020
Event Type  Death  
Manufacturer Narrative
This report has been identified as b. Braun medical inc. Internal report number (b)(4). The investigation into this reported event is ongoing. A follow-up report will be submitted when the results of the investigation are available.
 
Event Description
As reported by user facility: a fatality occurred during a patient therapy. The caller stated that the belief is this was not a maching issue but a work flow issue. The caller stated he was informed not to provide any details.
 
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Brand NameDIALOG+
Type of DeviceDIALYZER, HIGH PERMEABILIT
Manufacturer (Section D)
B. BRAUN AVITUM AG - MELSUNGEN
schwarzenberger weg 73-79
melsungen, D-342 12
GM D-34212
Manufacturer (Section G)
B. BRAUN AVITUM AG - MELSUNGEN
schwarzenberger weg 73-79
melsungen, D-342 12
GM D-34212
Manufacturer Contact
jonathan severino
824 12th avenue
bethlehem, pa 
2408332
MDR Report Key10470853
MDR Text Key204870818
Report Number3002879653-2020-00006
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 Manufacturer
Source Type company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 09/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue Number710500L
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/25/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/25/2010
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/31/2020 Patient Sequence Number: 1
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