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U.S. Department of Health and Human Services

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

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B. BRAUN AVITUM AG - MELSUNGEN DIALOG+®  HIGH PERMEABILIT Back to Search Results
Catalog Number 710500KU
Device Problem Infusion or Flow Problem (2964)
Patient Problem Respiratory Distress (2045)
Event Type  Injury  
Event Description
As reported by the user facility: it was believed to be a blood pump issue. The patient was not breathing and pulse palpable. The patient was reinfused and breathing resumed prior to starting cpr or any other intervention. A (b)(6) year old male with diagnosis of hypertensive chronic kidney disease. The patient became unresponsive and stopped breathing retained pulse, became alert after blood returned, oxygen given, and a few sternal rubs. The patient was sent to emergency room (er) and discharged with no changes to ekg. Possible vasovagal response was considered as the patient had three very forceful sneezes just prior to loosing consciousness. No other interventions required.
 
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Brand NameDIALOG+® 
Type of DeviceHIGH PERMEABILIT
Manufacturer (Section D)
B. BRAUN AVITUM AG - MELSUNGEN
schwarzenberger weg 73-79
melsungen, D-342 12
GM D-34212
MDR Report Key8667341
MDR Text Key146959594
Report Number2521402-2019-00007
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 06/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number710500KU
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/04/2019
Distributor Facility Aware Date05/21/2019
Device Age8 YR
Event Location Outpatient Treatment Facility
Date Report to Manufacturer06/04/2019
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: 06/04/2019 Patient Sequence Number: 1
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