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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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BAXTER HEALTHCARE CORPORATION; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 1236161
Patient Problem Blood Loss (2597)
Event Date 06/09/2023
Event Type  malfunction  
Event Description
Patient had continuous renal replacement therapy (crrt) machine alarm: blood leak detection.Filter clotted and blood was unable to be returned at that time.Whole cell count without differential was drawn off effluent, red blood cell (rbc) count of 1 was detected.Two days later, the crrt machine again rang blood leak detection.There were multiple attempts from different nurses to trouble shoot.Baxter was called for assistance.Unsuccessful revival of circuit.Again, whole cell count was taken from effluent, 1 rbc was counted.The filter clotted from the machine being down so long.Blood again was unable to be returned to patient.Crrt machine was removed from circulation.New crrt machine and new filter and new effluent in use now.
 
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Type of Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
one baxter parkway
deerfield IL 60015
MDR Report Key17396357
MDR Text Key319759115
Report Number17396357
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
Report Date 06/20/2023
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 Catalogue Number1236161
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/20/2023
Event Location Hospital
Date Report to Manufacturer07/26/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/26/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age20075 DA
Patient SexMale
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