• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BAXTER HEALTHCARE CORPORATION GAMBRO PHOENIX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameGAMBRO PHOENIX
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
one baxter parkway
deerfield IL 60015
MDR Report Key12210585
MDR Text Key262898269
Report Number12210585
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received07/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number6023006700
Device Catalogue Number103453
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/16/2021
Event Location No Information
Date Report to Manufacturer07/22/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

-
-