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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. DIALOG+; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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B. BRAUN MEDICAL, INC. DIALOG+; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 710200L
Device Problems Pumping Stopped (1503); Obstruction of Flow (2423); Unexpected Shutdown (4019)
Patient Problem Insufficient Information (4580)
Event Date 05/11/2021
Event Type  malfunction  
Event Description
Dialysis machine alarming with "system abort" message.Machine stopped blood pump.Rn manually returning patient blood.Machine was re-started and treatment resumed with blood pump running.Machine alarmed again with "system abort" and blood pump shut off.Rn began manual return of patient blood.Ebl 200ml, venous system appeared clotted.New machine brought into service.
 
Event Description
Dialysis machine alarming with "system abort" message.Machine stopped blood pump.Rn manually returning patient blood.Machine was re-started and treatment resumed with blood pump running.Machine alarmed again with "system abort" and blood pump shut off.Rn began manual return of patient blood.Ebl 200ml, venous system appeared clotted.New machine brought into service.
 
Event Description
Dialysis machine alarming with "system abort" message.Machine stopped blood pump.Rn manually returning patient blood.Machine was re-started and treatment resumed with blood pump running.Machine alarmed again with "system abort" and blood pump shut off.Rn began manual return of patient blood.Ebl 200ml, venous system appeared clotted.New machine brought into service.
 
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Brand Name
DIALOG+
Type of Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
B. BRAUN MEDICAL, INC.
824 twelfth avenue
bethlehem PA 18018
MDR Report Key12134499
MDR Text Key260478391
Report Number12134499
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 Risk Manager
Type of Report Initial,Followup,Followup
Report Date 06/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number710200L
Device Catalogue Number710200L
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/16/2021
Event Location Hospital
Date Report to Manufacturer07/08/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/08/2021
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received07/22/2021
07/22/2021
Type of Device Usage Unknown
Patient Sequence Number1
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