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

Catalog Number	114745
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Diarrhea (1811); Hemolysis (1886); Sweating (2444)
Date of Event	12/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that approximately three hours into treatment with a revaclear 300 dialyzer, a patient experienced a sudden symptomatic haemolysis reported as dark urine, abdominal pain, clamminess and diarrhea.The patient was treated with gaviscon 15 ml, pantoprazole 40 mg intravenously and litalgin 10mg/ml intravenously.Treatment was terminated with blood return, and the patient returned home.It was reported that the patient presented to the hospital the "next day" and was diagnosed with hemolysis and was hospitalized.No medical intervention during the hospitalization was reported.At the time of this report, the patient was reported to have recovered and ¿back to previous condition¿.No additional information is available.
Additional Manufacturer Narrative
Additional information: adverse event problem.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.

• Brand Name: REVACLEAR 300
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER; hechingen
• MDR Report Key: 8249978
• Report Number: 9611369-2018-00161
• Device Sequence Number: 14000840
• Product Code: KDI
• UDI-Device Identifier: 07332414114916
• UDI-Public: (01)07332414114916
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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,Followup
• Report Date (Section B): 01/31/2019

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: 07/31/2021
• Device Catalogue Number: 114745
• Device Lot Number: 8-9248-H-01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/20/2018
• Supplement Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 01/15/2019
• Supplement Report FDA Received Date: 01/31/2019
• 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: AK 98; NOVALINE BL207
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 115