• 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+®  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+®  HIGH PERMEABILIT Back to Search Results
Catalog Number 710500KU
Device Problem Infusion or Flow Problem (2964)
Patient Problem Respiratory Distress (2045)
Event Type  Injury  
Manufacturer Narrative
(b)(4). The device involved was inspected onsite by a b. Braun service team member. A safety test was performed without any anomalies. All values were within tolerance. A 15 minute mock treatment was performed and the machine performed as expected without alarms. The trend data was reviewed and multiple venous alarms occurred throughout treatment, both high and low. If additional pertinent information becomes available a follow-up report will be filed.
 
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
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 Key8667344
MDR Text Key146972119
Report Number3002879653-2019-00007
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 Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/04/2019
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?
Event Location No Information
Date Manufacturer Received05/21/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/13/2011
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: 06/04/2019 Patient Sequence Number: 1
-
-