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

Model Number 6023006700

Device Problems Improper Flow or Infusion (2954); Output Problem (3005); Pressure Problem (3012)

Patient Problem Insufficient Information (4580)

Event Date 06/29/2021

Event Type  malfunction  

Event Description

Patient post weight is about 2.9kg lower than pre weight.Net uf (ultrafiltration) removed is 1.09l during dialysis, hemodialysis (hd) machine has been showing d1-d2 error messages, reset hd machine and d1-d2 error messages stop showing.In the last 45 minutes d1-d2 error messages kept showing again and about 30 minutes remaining the venous pressure went up to 300s.We decided to stop hd in order to prevent bloodline clotting and be able to return pt's blood.Crit line was steep 'c' (meaning a rapid decrease in blood volume), min ultrafiltration (uf) was enabled.After hd tx (treatment) ended net=ultrafiltration (uf) removed is 1.09l, during post weighing patient weight is (b)(6) of pre-weight.Patient.Complains of feeling "dry", post bp=129/73, hr=78, no complaint of pain.Discharged w/ father of patient (fop).Tagged hd machine and diagnose its uf function.Checking pre and post weights thrice.Patient was on treatment, errors keeps showing after rn reset the machine.To prevent the blood from clotting, machine was swapped due to the constant error messages.This event caused minimal temporary harm.The machine has been removed from use.

• Brand Name: GAMBRO PHOENIX
• 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: 12210585
• MDR Text Key: 262898269
• Report Number: 12210585
• 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: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 6023006700
• Device Catalogue Number: 103453
• 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: 07/16/2021
• Date Report to Manufacturer: 07/22/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 6935 DA