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 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).

• 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: 10704467
• MDR Text Key: 212111658
• Report Number: 10704467
• 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 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