MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION BAXTER PRISMAX. SERIAL NUMBER 109333; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number PRISMAX

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Insufficient Information (4580)

Event Date 12/20/2021

Event Type  malfunction  

Event Description

Crrt machine red alarmed and entire screen turned red error message "software error heap exhausted".Bedside rn, clinical manager, and charge rn responded to alarm immediately.Baxter service representative contacted.Unable to clear error and machine had to be turned off.Hemodialysis catheter heparin locked.Fda safety report id# (b)(4).

• Brand Name: BAXTER PRISMAX. SERIAL NUMBER 109333
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 13111064
• MDR Text Key: 283087426
• Report Number: MW5106316
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/23/2021

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 Model Number: PRISMAX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 10 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic