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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 Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/28/2020
Event Type  malfunction  
Event Description
Sn (b)(4) had the same error for two consecutive classes. The machine set up correctly and started running the therapy. Within 10 min or so the user selected the wrench key to adjust the deaeration chamber then the machine stopped with a critical alarm stating to stop treatment and have the machine serviced. There were no options to continue. On both days, it would not allow for blood return and i had to work the auto-effluent set off of the side since it wouldn't ever unload it. I called icon baxter helpline when i couldn't get it off thinking there may be another way and the clinician confirmed it was best to just "work it off". It still leaves the clips pulled back in the lock position. The clinician stated she had gotten multiple reports about this same issue. I reported my concern about forcing it off the machine to baxter rep and our baxter educator. I am concerned additional damage could occur due to "working it off". I do not have the serial numbers for the second machine. Sn (b)(4): screen froze for approx. 4 minutes while therapy was running. It cleared once it did a system check. We confirmed there were no alarms creating this event. Also confirmed the screen was not on lock. After it unfroze, no further issues. Sn (b)(4): after system prime, while filling deaeration chamber, the screen went to error arps system failed #81273 (errors reported on 8/18 and 8/28- (i am unsure if machine was repaired twice). Sn (b)(4): during priming screen went to error arps system failed #81273. Sn (b)(4): during priming, error #t1281 stated the effluent bags were on the wrong scales. Confirmed lines were not clamped, bags were appropriately placed, cassette installed correctly while loading. Confirmed all resolution steps were completed. Would not allow us to bypass the screen or uninstall the ae set. While powering down, ae set had to be worked off of the side, it would not unload.
 
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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 Key10704468
MDR Text Key212111120
Report Number10704468
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 an Adverse Event Report? No
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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