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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
Model Number 710200S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 01/11/2019
Event Type  Death  
Manufacturer Narrative
(b)(4). Neither the device involved nor the trend data has been received for evaluation. The investigation is ongoing at this time. A follow-up report will be filed when the investigation is complete.
 
Event Description
As reported by the user facility: it was reported that a patient expired while on the machine having a treatment. The technician indicated that the machine was running fine and had nothing to do with the patient expiring. Updated information was received that the patient did not expire on the machine. The patient coded during dialysis while connected to the machine. The patient was extremely sick and had multiple comorbidities. The machine functioned properly. No patient information was provided.
 
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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
Manufacturer (Section G)
B. BRAUN AVITUM AG - MELSUNGEN
schwarzenberger weg 73-79
melsungen, D-342 12
GM D-34212
Manufacturer Contact
jonathan severino
861 marcon blvd
allentown, PA 18109
4847197287
MDR Report Key8288804
MDR Text Key134468202
Report Number3002879653-2019-00001
Device Sequence Number1
Product Code KDI
UDI-Device Identifier04046964285608
UDI-Public(01)04046964285608
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K083460
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 03/13/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/30/2019
Is this an Adverse Event Report? Yes
Device Operator
Device Model Number710200S
Device Catalogue Number710200S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/13/2019
Distributor Facility Aware Date01/18/2019
Event Location Outpatient Treatment Facility
Date Report to Manufacturer03/13/2019
Date Manufacturer Received01/18/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/02/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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