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

Catalog Number 114745

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

Patient Problems Abdominal Pain (1685); Diarrhea (1811); Hemolysis (1886); Sweating (2444)

Event Date 12/10/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event 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.

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
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER; hechingen
• MDR Report Key: 8249978
• MDR Text Key: 133213188
• Report Number: 9611369-2018-00161
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414114916
• UDI-Public: (01)07332414114916
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 12/20/2018
• Initial Date FDA Received: 01/15/2019
• Supplement Dates Manufacturer Received: 01/14/2019
• Supplement Dates FDA Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AK 98; NOVALINE BL207
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 115