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

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.

• Brand Name: REVACLEAR MAX
• Type of Device: DIALYZER, 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 Key: 6948751
• MDR Text Key: 89353330
• Report Number: 3006552611-2017-00059
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060195
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• 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 Received: 10/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 110634
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other