• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BAXTER HEALTHCARE CORPORATION PRISMAXPRISMAX SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 955626
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/27/2020
Event Type  malfunction  
Event Description
These machines had system failures and required repair due to an arps system failure alarm (b1273). This error does not allow any actions other than discontinue treatment. (b)(4). Additionally, there were two machines that had the auto-effluent cassette loaded, but it would not release for removal during shutdown. One occurred during class and (baxter educator) was able to help resolve it through restarting the machine and re-shutting it down. The second one could not be resolved. We ended up working it off of the side. The machine was able to be set up on a subsequent use without difficulty. Neither of these events created a work order but were witnessed during class time by the educator. While baxter engineering was in-house, he was asked to replace/repair the rubber stopper on two of the thermax blood warmers. The rubber stopper at the bag insertion area becomes loose and prevents the blood warmer bag from advancing into the warmer. He was able to secure both of these stoppers while present for the other repairs. Manufacturer response for baxter prismax crrt machine, (brand not provided) (per site reporter).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePRISMAXPRISMAX SYSTEM
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 Key10704467
MDR Text Key212111658
Report Number10704467
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 09/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/20/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model Number955626
Device Catalogue Number955626
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/09/2020
Event Location Hospital
Date Report to Manufacturer10/20/2020
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

-
-