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

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.

• Brand Name: PRISMAXPRISMAX SYSTEM
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; one baxter parkway; deerfield IL 60015
• MDR Report Key: 10704468
• MDR Text Key: 212111120
• Report Number: 10704468
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 955626
• Device Catalogue Number: 955626
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/09/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/20/2020
• 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