MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. PRISMAFLEX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Device Problems Material Deformation (2976); Air/Gas in Device (4062)

Patient Problem Insufficient Information (4580)

Event Date 06/07/2022

Event Type  malfunction  

Event Description

Crrt prismaflex machine failed.De-aeration chamber rapidly depleted and machine alarmed for "air in blood" and return pressure too positive.Rn followed procedure to correct alarm, and although resolved initially, the same alarm occurred again.Rn found that pbp and dialysate bags were dry with no prompt from machine to change.Bags changed and attempted de-aeration, but filter then clotted.

• Brand Name: PRISMAFLEX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 15224316
• MDR Text Key: 297879319
• Report Number: 15224316
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 08/04/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/04/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/15/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/15/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16060 DA
• Patient Sex: Male