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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC DIALOG+ DIALYZER, HIGH PERMEABILIT

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B. BRAUN MEDICAL INC 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  
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 MEDICAL INC
schwarzenberger weg 73-79
melsungen, d-34212
GM
MDR Report Key11679697
MDR Text Key245822516
Report Number2521402-2021-00015
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 Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/16/2021
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? Yes
Date Report Sent to FDA04/16/2021
Distributor Facility Aware Date04/12/2021
Device Age10 YR
Event Location Outpatient Treatment Facility
Date Report to Manufacturer04/12/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/16/2021 Patient Sequence Number: 1
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