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

Catalog Number 114745L

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

Patient Problem Hemolysis (1886)

Event Date 08/04/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a patient undergoing dialysis treatment with a cartridge bloodline and revaclear 300 dialyzer experienced hemolysis.At an unknown time during treatment, the extracorporeal circuit clotted and the treatment was terminated with a blood loss of less than 100 ml.The treatment was later restarted and completed.The patient was hospitalized for monitoring as hemolysis was suspected to have occurred during the first treatment.There was no medical intervention during hospitalization.The patient was reported to be in stable condition at the time of this report.No additional information is available.

Manufacturer Narrative

The sample was receive by baxter for evaluation.A blood leak test (opl-wins-1257) was performed and it failed.The leak was verified from inside the fiber bundle on the dmc side of the dialyzer.All other parameters for fiber inspection passed.There were no issues with the gasket position and/or pur defects.The retained sample was tested as well, and it passed all parameters of inspection.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.The device was manufactured between 18may2018 through 19may2018.

• Brand Name: REVACLEAR
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - OPELIKA; opelika AL
• MDR Report Key: 7828216
• MDR Text Key: 118877367
• Report Number: 3006552611-2018-00009
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414123055
• UDI-Public: (01)07332414123055
• Combination Product (y/n): N
• PMA/PMN Number: K130039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/29/2018,09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2021
• Device Catalogue Number: 114745L
• Device Lot Number: C418113801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/29/2018
• Distributor Facility Aware Date: 08/29/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/29/2018
• Date Manufacturer Received: 08/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTRIDGE; NORMAL SALINE; PHOENIX MACHINE
• Patient Outcome(s): Hospitalization
• Patient Age: 64 YR
• Patient Weight: 100