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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - OPELIKA REVACLEAR MAX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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BAXTER HEALTHCARE - OPELIKA REVACLEAR MAX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 110634
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Hemolysis (1886); Vomiting (2144)
Event Date 09/18/2017
Event Type  Injury  
Manufacturer Narrative
The actual device was not available for evaluation; therefore, a device analysis could not be completed. The batch number is unknown therefore, a batch review cannot be conducted. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
This is a report of a patient who was admitted to the emergency room due to hemolysis following hemodialysis therapy using a phoenix machine, revaclear max dialyzer, and cartridge bloodlines. The patient presented for their dialysis session with no reported issues. During treatment, the patient had a high venous pressure. The patient received a saline flush, and the blood flow rate was turned down. Approximately five minutes before the end of the treatment, the circuit clotted. Treatment was interrupted without returning the blood to the patient. The patient did not present symptoms at that time. Approximately one hour later, the patient presented to the emergency room with abdominal pain, vomit, and feeling bad (further clarification not provided). Blood tests confirmed the presence of hemolysis. No further patient, treatment, or laboratory data was provided. No additional information is available.
 
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Brand NameREVACLEAR MAX
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE - OPELIKA
opelika AL
Manufacturer (Section G)
BAXTER HEALTHCARE - OPELIKA
1101 jeter ave
opelika AL 36801
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key6948751
MDR Text Key89353330
Report Number3006552611-2017-00059
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 10/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number110634
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 Received09/18/2017
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: 10/13/2017 Patient Sequence Number: 1
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