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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 710200L
Device Problem Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem Blood Loss (2597)
Event Date 10/23/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Neither the device involved nor the trend date 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: customer reported the machine locked up with a blank screen and the blood pump stopped. The patient's blood clotted and the patient had to be removed, losing 100cc of blood. Patient was stable after blood loss. Blood pressure (bp) was maintained and no signs or symptoms of distress were observed or reported.
 
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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 Key8051228
MDR Text Key128272509
Report Number3002879653-2018-00010
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K963440
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/27/2018,11/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number710200L
Device Catalogue Number710200L
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/27/2018
Distributor Facility Aware Date10/25/2018
Event Location Hospital
Date Report to Manufacturer12/27/2018
Date Manufacturer Received10/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/08/2018
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: 11/08/2018 Patient Sequence Number: 1
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