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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Insufficient Information (4580)
Event Date 04/06/2021
Event Type  Death  
Manufacturer Narrative
This report has been identified as b. Braun medical inc. Internal report number 400510461. The device involved has not been received for evaluation and 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 cardio pulmonary incident during treatment and was taken to the emergency room and expired. The facility further reported that a sample of the dialysis fluid was taken. The potassium concentration appeared to be high. A new sample was sent for re-testing. The facility mixes the acid concentrate for the dialysis fluid on site.
 
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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 18018-0027
4847197287
MDR Report Key11679698
MDR Text Key245822632
Report Number3002879653-2021-00015
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received04/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/09/2010
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: 04/16/2021 Patient Sequence Number: 1
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