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

Model Number 955626

Device Problems Filling Problem (1233); Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 04/15/2021

Event Type  malfunction  

Event Description

The new prismax continuous veno-venous hemofiltration (cvvh) machine was primed and attached to patient without any problems.Shortly after attaching to patient while machine was up and running the deaeration chamber began accumulating foam and the fluid level started dropping quickly.This nurse was watching the chamber very carefully trying to keep it filled to the adequate amount while not allowing the foam to reach the sensor above.The foam continued to accumulate and it set off the sensor causing an alarm which stopped the circuit from running.This nurse tried to return the blood right away but the machine would not allow.Also this all happened very quickly and there was not time to call the machine hotline for help.The blood was not returned to patient and the trauma team was notified as well as nurse educator and charge rn manufacturer response for cvvh machine, prismax system (per site reporter): baxter service engineer came on-site and was not able to duplicate the reported condition.Engineer performed liquid level sensor sst as per manufacturer procedures and it passed.Also, performed simulated therapy with no unexplained alarms.The machine has been returned back into service.

• Brand Name: PRISMAX SYSTEM
• 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: 12084569
• MDR Text Key: 258926651
• Report Number: 12084569
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/21/2021

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: 955626
• Device Catalogue Number: 955626
• Device Lot Number: 955626
• 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: 06/21/2021
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/29/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 9125 DA
• Patient Weight: 54