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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION PRISMAX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 955626
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Hemorrhage/Bleeding (1888)
Event Description
Both prismax and prismaflex have had ongoing multisystem device failures leading to adverse patient events, unintended blood loss, known issues with fluid removal due to scale inaccuracies, hardware and software issues, arps tubing failures, additional filter changes, lost patient treatment time and the potential additional clinician exposure to covid due to this device being used in the icu on covid patients. Baxter is aware of these issues and have demanded that employees not put anything in writing including email, instant messaging or microsoft teams messaging any device issues, in an attempt to not have an fda product recall prohibiting the sale of the prismax and prismaflex device. (b)(4). (b)(6).
 
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Brand NamePRISMAX
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
1 baxter parkway
deerfield IL 60015
MDR Report Key13385277
MDR Text Key284981299
Report NumberMW5107033
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 01/20/2022
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received01/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Catalogue Number955626
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided

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