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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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BAXTER HEALTHCARE CORPORATION PRISMAFLEX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Device Problems Coagulation in Device or Device Ingredient (1096); Increase in Pressure (1491)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/11/2019
Event Type  malfunction  
Event Description
Noticed that there were high return pressure alarms.I went into assess the situation and noticed that there was air pulling from the access line.It alarmed again stating return line disconnection.I made sure that all connections were secure, which they were.We concluded that the filter was clotted, and that we needed to return the blood.We cautiously, monitored the filter and went to return the blood.The air had dissipated enough to safely return.Upon returning the blood, the filter alarmed return pressure was high.We investigated even closer, noticed that there was a clot in the return line of the hemodialysis cath.We aspirated the clot as well as 20 cc of blood and did not return the rest of the blood.
 
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Brand Name
PRISMAFLEX
Type of Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
32650 n. willson blvd wgl-3n
round lake IL 60073
MDR Report Key10133275
MDR Text Key194497594
Report Number10133275
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 05/26/2020,10/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/26/2020
Event Location Hospital
Date Report to Manufacturer06/09/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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