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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION BAXTER PRISMAFLEX HEMODIALYSIS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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BAXTER HEALTHCARE CORPORATION BAXTER PRISMAFLEX HEMODIALYSIS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 955542
Device Problem Product Quality Problem (1506)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  No Answer Provided  
Event Description
(b)(4). Baxter prisma flex hemodialysis units. Per baxter request we have downloaded your form. The alert has been sent out to nursing mgmt to inform staff to not use extension tubing for covid 19 pts on any pts due to possible issues. (b)(6), lead biomed tech. (b)(6) 2020.
 
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Brand NameBAXTER PRISMAFLEX HEMODIALYSIS
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
MDR Report Key9962015
MDR Text Key187747393
Report NumberMW5094129
Device Sequence Number5
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
7 Devices were Involved in the Event: 1   2   3   4   5   6   7  
0 Patients were Involved in the Event:
Date FDA Received04/14/2020
Device Operator
Device Model Number955542
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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