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

Device Problems Disconnection (1171); Fluid/Blood Leak (1250); Communication or Transmission Problem (2896); Temperature Problem (3022)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/11/2023

Event Type  malfunction  

Event Description

Patient was on prismax continuous renal replacement therapy machine and blood warmer when the machine first alarmed with heater level misaligned.Second alarm with heater over regulated.Third alarm read heater miscommunication, disconnected.Fourth alarm read blood leak detected and would not reset or allow blood to be rinsed back.Spoke with icon representative who was notified during the alarm process.Unable to return blood.Machine sent to biomed per icon request.

• 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: 17030288
• MDR Text Key: 316211326
• Report Number: 17030288
• 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: 12410 DA
• Patient Sex: Male
• Patient Weight: 107 KG
• Patient Ethnicity: Hispanic
• Patient Race: White