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

Device Problems Backflow (1064); Defective Device (2588)

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

Event Date 05/01/2023

Event Type  malfunction  

Event Description

Crrt prismax system failed twice within one shift.The first system failure, i was able to recover by turning the machine off, then back on, and hitting continue.A couple hours later, another system failure occurred and the machine was not able to be recovered and blood could not be returned.Manufacturer response for baxter prismax crrt machine, prismax (per site reporter) user facility has been working closely with baxter including multiple site visits for over two and a half years in an attempt to identify the problems and fix the problems.

• Brand Name: PRISMAX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 25212 w. illinois route 120; round lake IL 60073
• MDR Report Key: 17030338
• MDR Text Key: 316214758
• Report Number: 17030338
• 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: 05/15/2023

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/15/2023
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/31/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/31/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 22265 DA
• Patient Sex: Male
• Patient Weight: 128 KG
• Patient Race: White