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

Device Problems Device Alarm System (1012); Computer Software Problem (1112)

Patient Problem Insufficient Information (4580)

Event Date 02/10/2021

Event Type  malfunction  

Event Description

While a patient was on crrt (continuous renal replacement therapy) treatment, false pressure parameter alarms sounded.Clinician called nurse and nurse educator into the room to review alarm and assist in trouble shooting.After reviewing the alarms and attempting to troubleshoot, baxter was called for support.Previous documentation of pressure parameters was reviewed but no indication of additional issues except that the circuit was likely clotted off.Decision was made not to return blood to the patient due to risk of clotting.No indications of increased pressure were noted from the documentation.Alarms that were triggered: t1169 return disconnection, t0822 flow problem, t1552 effluent low flow rate, and t1145 check access.Manufacturer response for hemodialysis, prismax (per site reporter): baxter has investigated this and several other machines with the same issues.They believe it is a software issue and is working on updating the entire fleet.

• Brand Name: PRISMAX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; one baxter parkway; deerfield IL 60015
• MDR Report Key: 11403975
• MDR Text Key: 234476592
• Report Number: 11403975
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/23/2021

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/23/2021
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/03/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1