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

MAUDE Adverse Event Report: GAMBRO RENAL PRODUCTS REVACLEAR MAX 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
 

GAMBRO RENAL PRODUCTS REVACLEAR MAX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number REVACLEAR MAX
Device Problem Insufficient Information (3190)
Patient Problem Hemolysis (1886)
Event Date 12/19/2016
Event Type  Injury  
Manufacturer Narrative
Na.
 
Event Description
A patient was undergoing a dialysis treatment which included a phoenix machine, cartridge blood line and revaclear max dialyzer. The patient has two vascular access sites; a right upper arm av fistula and a tunneled right subclavin hd catheter. Due to several months of difficulty cannulating the fistula, the arterial blood line was connected to the catheter and the venous line connected to the av fistula via a 17 gauge needle. During the last 30 minutes of the dialysis treatment on (b)(6) , the venous needle infiltrated with active bleeding. Treatment was terminated and pressure applied to the site; bleeding eventually stopped and the patient was discharged home in stable condition. The following day the patient was admitted to the hospital with hematuria and dizziness. The patient's lab work revealed anemia and was also suggestive of hemolysis; the urine analysis confirmed a urinary tract infection. The patient's vital sings were stable, afebrile, no back pain, no frank bleeding and no signs of anything hemodynamically significant. The patient was transfused with a unit of blood. The hematuria spontaneously resolved and the patient was discharged from the hospital a few days later. The phoenix machine was inspected and found to be operating within manufacturer's specification. The disposables used at the time of treatment were discarded and no longer available for analysis.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameREVACLEAR MAX
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
GAMBRO RENAL PRODUCTS
1101 jeter avenue
opelika AL
Manufacturer (Section G)
GAMBRO RENAL PRODUCTS
1101 jeter avenue
opelika AL 36801
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2249487578
MDR Report Key6266269
MDR Text Key65374391
Report Number3006552611-2017-00001
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060195
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 01/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberREVACLEAR MAX
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/20/2017 Patient Sequence Number: 1
Treatment
PHOENIX, CARTRIDGE
-
-