• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

B. BRAUN AVITUM AG - MELSUNGEN DIALOG+®  DIALYZER, HIGH PERMEABILIT Back to Search Results
Catalog Number 710500K
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Cardiac Arrest (1762)
Event Date 03/02/2022
Event Type  Death  
Manufacturer Narrative
This report has been identified as b. Braun medical inc. Internal report number (b)(4). The investigation is ongoing at this time. A follow up will be submitted when the investigation results become available.
 
Event Description
As reported by user facility: a patient had a code episode and passed away. The machine was removed from service. Pyrogen and bacteriology samples were collected and tested with negative results. The machine was run in simulated treatment mode twice. The dialysate temperature calibration had drifted (34. 3°c external meter, machine indicated 37. 0°c). The conductivity calibration had also drifted (14. 331ms/cm external meter, machine endlf indicated 13. 7ms/cm; endlf_s indicated 14. 1ms/cm). The ph was 7. 5. An electrical safety check was run and no problem was found. There was no level of patient electrical leakage found.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 18018-0027
4847197287
MDR Report Key13741319
MDR Text Key287100393
Report Number3002879653-2022-00017
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 Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number710500K
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/16/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/11/2022 Patient Sequence Number: 1
-
-