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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 Device Alarm System (1012); Device Displays Incorrect Message (2591)
Patient Problems Cardiac Arrest (1762); Death (1802)
Event Date 02/10/2021
Event Type  malfunction  
Event Description
Infant in severe distributive shock and renal failure was placed on crrt with an hf 20 filter in the early evening. Patient continued to have severe vasodilatory shock requiring fluid administration to maintain hemodynamics. Patient had worsening pulmonary edema and hypoxia as well as st segment changes indicating cardiac distress. In the morning, the patients baxter prismaflex had a self-test failure alert. The alarm was safely over-ridden while another circuit was prepared but was continuing to alarm multiple times while preparing a new circuit. This transition was discussed with the family who requested that we proceed. An hf 1000 was chosen as the filter with the new circuit due to desire to try therapeutic plasma exchange if possible. During the initiation of the new circuit, the patient had a cardiac arrest. Cpr was initiated but discontinued at the parents request. In light of the patients illness and deterioration, changing the circuit did not change the trajectory of this illness and was not the ultimate cause of the patients death. A manufacturer fda urgent medical device correction is in process for the baxter prismaflex machines with the plan to replace the aprs tubing for machines that are experiencing this issue.
 
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Brand NamePRISMAFLEX
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
one baxter parkway
deerfield IL 60015
MDR Report Key11378013
MDR Text Key233471620
Report Number11378013
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 02/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/19/2021
Event Location Hospital
Date Report to Manufacturer02/25/2021
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 Unkown

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