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

Catalog Number 955626

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hemorrhage/Bleeding (1888)

Event Description

Both prismax and prismaflex have had ongoing multisystem device failures leading to adverse patient events, unintended blood loss, known issues with fluid removal due to scale inaccuracies, hardware and software issues, arps tubing failures, additional filter changes, lost patient treatment time and the potential additional clinician exposure to covid due to this device being used in the icu on covid patients.Baxter is aware of these issues and have demanded that employees not put anything in writing including email, instant messaging or microsoft teams messaging any device issues, in an attempt to not have an fda product recall prohibiting the sale of the prismax and prismaflex device.(b)(4).(b)(6).

• Brand Name: PRISMAX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 1 baxter parkway; deerfield IL 60015
• MDR Report Key: 13385277
• MDR Text Key: 284981299
• Report Number: MW5107033
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/20/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Catalogue Number: 955626
• Patient Sequence Number: 1