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

Device Problems Device Alarm System (1012); Device Displays Incorrect Message (2591)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 02/10/2021

Event Type  malfunction  

Event Description

Infant in severe distributive shock and renal failure was placed on crrt with an hf 20 filter in the early evening.Patient continued to have severe vasodilatory shock requiring fluid administration to maintain hemodynamics.Patient had worsening pulmonary edema and hypoxia as well as st segment changes indicating cardiac distress.In the morning, the patients baxter prismaflex had a self-test failure alert.The alarm was safely over-ridden while another circuit was prepared but was continuing to alarm multiple times while preparing a new circuit.This transition was discussed with the family who requested that we proceed.An hf 1000 was chosen as the filter with the new circuit due to desire to try therapeutic plasma exchange if possible.During the initiation of the new circuit, the patient had a cardiac arrest.Cpr was initiated but discontinued at the parents request.In light of the patients illness and deterioration, changing the circuit did not change the trajectory of this illness and was not the ultimate cause of the patients death.A manufacturer fda urgent medical device correction is in process for the baxter prismaflex machines with the plan to replace the aprs tubing for machines that are experiencing this issue.

• Brand Name: PRISMAFLEX
• 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: 11378013
• MDR Text Key: 233471620
• Report Number: 11378013
• 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: 02/19/2021

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: No Information
• 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: 02/19/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/25/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 12 DA
• Patient Weight: 3