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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B.BRAUN AVITUM AG DIALOG+® DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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B.BRAUN AVITUM AG DIALOG+® DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 710200K
Device Problems No Display/Image (1183); Loss of Power (1475)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/08/2018
Event Type  malfunction  
Event Description
During dialysis treatment b braun machine shut down. Screen went black. No power. Machine was plugged into red outlet. Wro was also plugged in and did not lose power. No other power down or loss of power in room except for b braun machine. From biomed: the unit in question was run for a 4 hr run and a citric/thermal yesterday (5 hrs total on time), then a full pm was performed today. There was nothing found during pm or the repair check that would bear on this issue or cause the unit to shut down. Unit was powered on from 7:30am till 4:30pm while pm, qa, and finally decalc/thermal were performed today (9 more hrs total on time). Most likely cause would be hospital power related (momentary sag in line voltage) but cannot substantiate as boiler operator couldn't provide any possible cause such as generator testing and there were no notes of any power issues left by maintenance either.
 
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Brand NameDIALOG+®
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
B.BRAUN AVITUM AG
901 marcon blvd.
allentown PA 18109
MDR Report Key8284866
MDR Text Key134337309
Report Number8284866
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/29/2019
Is this a Product Problem Report? Yes
Device Operator
Device Model Number710200K
Device Catalogue Number710200K
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/14/2018
Event Location Hospital
Date Report to Manufacturer01/29/2019
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

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