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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAX AUTO EFFLUENT; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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BAXTER HEALTHCARE CORPORATION PRISMAX AUTO EFFLUENT; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 115370
Device Problems Leak/Splash (1354); Audible Prompt/Feedback Problem (4020)
Patient Problem Insufficient Information (4580)
Event Date 02/13/2023
Event Type  malfunction  
Event Description
Patient with crrt set up with auto effluent cartridge, a few minutes after starting, an alarm sounded that there was fluid in the bottom of the machine.Noted that the auto effluent cartridge was leaking at the connection of the small effluent bag that hangs from the back of the machine.Cartridge removed from use and saved.Prismax auto effluent, lot# 22|0601, ref# 115370, infor# (b)(4).Manufacturer response for auto effluent cartridge, prismax auto effluent (per site reporter).[redacted name] picking up on [redacted date].[redacted date] - reported event to baxter renal and requested rma and mailer.[redacted date] - baxter reported the return kit is held up at ups.[redacted date] - rma/mailer kit received product shipped ups.
 
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Brand Name
PRISMAX AUTO EFFLUENT
Type of Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
25212 w. illinois route 120
round lake IL 60073
MDR Report Key17236791
MDR Text Key318214641
Report Number17236791
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 Other Health Care Professional
Type of Report Initial
Report Date 06/21/2023
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 Number115370
Device Lot Number220601
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/22/2023
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/21/2023
Event Location Hospital
Date Report to Manufacturer06/30/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/30/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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