MAUDE Adverse Event Report: BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER REVACLEAR 400; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	114746
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Nausea (1970); Chills (2191); Malaise (2359)
Date of Event	02/06/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that 18 patients using a revaclear 400 experienced chills, headache, malaise and nausea during therapy.The patients were treated with 100mg of hydrocortisone intravenously, 75mg of diclofenac, 3lt x1mts of oxygen and 1g of vancomycin was administered intravenously.It was reported that the patients improved after treatment.No additional information is available.

• Brand Name: REVACLEAR 400
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER; hechingen
• MDR Report Key: 8386195
• Report Number: 9611369-2019-00021
• Device Sequence Number: 2171023
• Product Code: KDI
• UDI-Device Identifier: 07332414114923
• UDI-Public: (01)07332414114923
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K130039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 114746
• Device Lot Number: 8-9441-H-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 03/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NON BAXTER PRODUCT; POLYFLUX 170H
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention