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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B.BRAUN AVITUM AG PHOENIX DIALYSIS MACHINE B12; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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B.BRAUN AVITUM AG PHOENIX DIALYSIS MACHINE B12; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Lot Number 710200L
Device Problems Defective Alarm (1014); Infusion or Flow Problem (2964)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/18/2023
Event Type  malfunction  
Event Description
The dialysis machine past all test prior treatment commencing.Patient connected and soon after about 20 minutes there was a persistent blood leak alarm.The system was switched with new consumables and the treatment re-started again.Soon after this, there was a persistent alarm of conductivity, and troubleshooting done by several staff members could not resolve the problem.The machine failed to pick up conductivity even after using different bicarbonate formulas available.A decision was arrived at, to discontinue the treatment and get another machine to dialyze the patient.
 
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Brand Name
PHOENIX DIALYSIS MACHINE B12
Type of Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
B.BRAUN AVITUM AG
824 twelfth avenue
bethlehem PA 18018
MDR Report Key16689027
MDR Text Key312772106
Report Number16689027
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 Nurse
Type of Report Initial
Report Date 03/23/2023
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 Lot Number710200L
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/23/2023
Event Location Outpatient Treatment Facility
Date Report to Manufacturer04/06/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/06/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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