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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

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BAXTER HEALTHCARE CORPORATION PRISMAXPRISMAX SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 955626
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/01/2020
Event Type  malfunction  
Event Description
We placed two patients on the prismax machines. The first machine started fine, the second and third machines had arps errors and the fourth machine worked fine. This delayed care and decreased the patient's therapy time. We had 2 machines that had the arps errors (b1273) when being set up on patients. Sn (b)(4): we were able to replicate the alarm during a conference call with our baxter educator while placing the machine into self-test mode. Sn (b)(4): we were unable to replicate the alarm when on the call with our baxter educator. The machine seemed to work fine when it was shutdown and restarted. I am unsure if it would continue to perform.
 
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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 Key10704242
MDR Text Key212110235
Report Number10704242
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

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