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 Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
Reportedly, a blood leak was detected 3 hours after the treatment began, at the connection of the revaclear 400 dialyzer to the arterial dialyzer line.The presence of coagulated blood was noted at the level of the inlet and outlet connectors of the dialyzer.According to the reporter, the arterial expansion chamber was under high pressure, a clot in the line was noticed, which in turn led to an overpressure on the venous line.The session was discontinued.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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.

• 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: 7393468
• Report Number: 9611369-2018-00032
• Device Sequence Number: 13739158
• Product Code: KDI
• UDI-Device Identifier: 07332414114923
• UDI-Public: (01)07332414114923
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 114746
• Device Lot Number: 7-7087-H-01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/08/2018
• Supplement Date Received by Manufacturer: 05/18/2018
• Initial Report FDA Received Date: 04/03/2018
• Supplement Report FDA Received Date: 05/18/2018
• 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 200 ULTRA S DIALYSIS MACHINE; NIPRO LINES