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

Catalog Number 114746L

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Chest Pain (1776); Dyspnea (1816); Low Blood Pressure/ Hypotension (1914)

Event Type  Injury  

Manufacturer Narrative

The patient is (b)(6) years of age.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that approximately 15-30 minutes during treatment with a revaclear dialyzer, the dialysis machine generated several "air in blood" alarms.Eventually the alarms cleared but no air or bubbles could be observed within the extra-corporeal circuit.As result of the alarms, the patient experienced shortness of breath and chest pain.Patient was placed in minimum ultrafiltration rate and in trendelenburg position and received saline due to hypotension.Reportedly the symptoms dissipated.No additional information is available.

• Brand Name: REVACLEAR
• 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: 7847329
• MDR Text Key: 119254500
• Report Number: 3006552611-2018-00011
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130039
• 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: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 114746L
• Device Lot Number: C418211501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/05/2018
• Distributor Facility Aware Date: 08/08/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/05/2018
• Initial Date Manufacturer Received: 08/08/2018
• Initial Date FDA Received: 09/05/2018
• 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
• Treatment: BLOOD CARTRIDGE; HOSPIRA 0.9% SALINE BAG; PHOENIX MACHINE; REXEED 25S DIALYZER (NON-BAXTER PRODUCT)
• Patient Outcome(s): Other