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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

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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 02/16/2017
Event Type  Injury  
Event Description
A patient was undergoing a dialysis treatment which included a revaclear max dialzyer. Three hours into treatment the patient complained of lower abdominal pain with an increased in bp. The patient requested to stop dialysis early. Upon disconnection the patient had a loose stool and later discharged home. While at home the patient continued with abdominal pain, nausea, vomiting, and diarrhea which eventually became bloody and her urine was dark red in color. The patient was taken to the hospital where she was admitted. The patient¿s initial blood work revealed some degree of hemolysis with an elevated ldh, hyperkalemia, and low haptoglobin. The cause of the hemolysis is unknown. The dialyzer was discarded and not available for analysis.
 
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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 Key6337634
MDR Text Key67647547
Report Number3006552611-2017-00003
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 Biomedical Engineer
Type of Report Initial
Report Date 02/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberREVACLEAR MAX
Device Catalogue Number103453
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/18/2017
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: 02/16/2017 Patient Sequence Number: 1
Treatment
PHOENIX MACHINE, CARTRIDGE BLOOD LINE
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