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

Device Problems Break (1069); Temperature Problem (3022)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Hypothermia (1915)

Event Date 06/02/2021

Event Type  malfunction  

Event Description

Prismaflex machines have a blood warmer attached to them.This patient is receiving crrt therapy therefore the blood warmer is needed to warm patient blood to prevent patient from becoming hypothermic.Blood warmer reading 43 degrees celsius however the tubing was cold, and the patient temperature dropped to 35.5 rectally.This caused patient to become bradycardic and hypotensive and experienced hypothermia.Equipment changed out with another heater from another prismaflex machine leaving that one unable to be used.Actions taken to ensure no patient harm.A bair hugger was placed, and fluid resuscitation and pressors (epinephrine and vasopressin drips) were initiated.Patients status improved after these interventions, but given instability of patient overnight, surgery scheduled for this morning was cancelled.Bio-med identified later that the insulated cable that holds the tubing was broken.

• 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: 11998860
• MDR Text Key: 256195055
• Report Number: 11998860
• 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: 06/10/2021

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: 06/10/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/15/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 120 DA