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

Catalog Number 955558

Device Problem Device Alarm System (1012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/25/2023

Event Type  malfunction  

Event Description

It was reported that after 10 minutes of continuous renal replacement therapy with a prismax control unit, air was observed coming from the access, which triggered the ¿access extremely negative¿ alarm.The treatment was terminated without returning the extracorporeal (ec) blood to the patient.The treatment was restarted with a different prismax machine, and the machine alarmed again after 20 minutes into therapy, resulting in treatment termination.The ec blood was not returned to the patient.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

The actual device was not returned for evaluation; however, the device was evaluated by an on-site local service engineer.The device was technically evaluated including performing arps compliance calibration, arps sst, pressure sensors sst, and liquid level sensor sst, and no issues were noted.Priming and simulated patient treatment procedure were also performed with no issues noted.The service engineer reviewed the log files and alarm logs, and it was verified that the reported alarms had occurred.The cause of the reported condition could not be determined.A device history review revealed no issues that could have caused or contributed to the reported issue.The machine was found to be performing as per specification and was readmitted to clinical service.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAX MACHINES
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - BROOKLYN PARK; 7601 northland drive; n suite 170; minneapolis MN 55428
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 17599590
• MDR Text Key: 321731860
• Report Number: 3003504604-2023-00021
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 955558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2023
• Initial Date FDA Received: 08/22/2023
• Supplement Dates Manufacturer Received: 09/29/2023
• Supplement Dates FDA Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: PRISMAFLEX SET.