• 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 PRISMAFLEX 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 PRISMAFLEX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 7.20
Device Problems Device Displays Incorrect Message (2591); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/06/2022
Event Type  malfunction  
Event Description
Continuous renal replacement therapy (crrt) machine is running a dialysis treatment the screen showed a "download error" message and it stop treatment and cannot continue per bedside nurse. Crrt machines typically run up to 3-5 days of continuous dialysis. Prior to the fatal "download error" message machine has "stable access and circuit pressure" per previous days rounding report. Crrt machine needs to be troubleshooted by biomed to study cause of and to prevent another "download error" message. Summary of work notes from biomed: start troubleshooting by performing a boot-up o. K. Contact tech support. Learn from him that 'download errors' are rare, and there shouldn't be errors during treatment because use of the card only occurs after or before treatment, with one caveat. If the card is full, which very seldom happens because it has a large capacity, a download error could occur. This is a machine that we acquired from stanford and it is relatively old, so it is possible that the card is full. Pending repair of the device is stored in lock-out/tag-out status. There was no harm in this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key13558604
MDR Text Key285818132
Report Number13558604
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 02/11/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number7.20
Device Catalogue Number955542
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/11/2022
Date Report to Manufacturer02/18/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Type of Device Usage Unkown

-
-