MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION REVACLEAR 300; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 114745L

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tachycardia (2095); Reaction (2414)

Event Date 11/25/2020

Event Type  Injury  

Manufacturer Narrative

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.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that after two and half hours of therapy using a revaclear 300, the patient experienced generalized pruritus without hemodynamic changes.At the time of the event, the oxygen saturation was 100%, fio2: 21% and heart rate of 59 bpm.Ten minutes later the patient presented with sinus tachycardia 90 bpm and ¿anxious allergy¿.Treatment was stopped and administration of hydrocortisone 200 mg intravenously was provided.The patient was observed for 30 minutes.It was reported the patient was ¿feeling well¿ and left without any symptoms.No additional information is available.

• Brand Name: REVACLEAR 300
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• 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: 11048106
• MDR Text Key: 222830975
• Report Number: 3006552611-2020-00010
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414123055
• UDI-Public: (01)07332414123055
• Combination Product (y/n): Y
• Reporter Country Code: CO
• PMA/PMN Number: K130039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/21/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/27/2023
• Device Catalogue Number: 114745L
• Device Lot Number: C620306802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2020
• Initial Date FDA Received: 12/21/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR