MAUDE Adverse Event Report: BAXTER HEALTHCARE - TIJUANA BAJA CARTRIDGE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number 101025

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

Correction was made to for sample receipt date.Two actual samples were received by baxter for evaluation.The two samples and eight retained samples were evaluated.The actual samples and retained samples were visually inspected looking for kinked lines or damaged components that could be related with the failure mode reported.All samples were within specification.Visual inspection of the blood tubes and filters was performed with a magnification lamp, looking for occlusions or filaments in the components.No defects were found.A verification was conducted by introducing a pin gage to confirm there was not a restriction and/or occlusion.A dimensional inspection of the length of arterial and venous dialyzer lines was performed on all samples and this met specifications.The reported condition was not verified.A device history review revealed no issues that could have caused or contributed to the reported issue.Should additional relevant information become available, a supplemental report will be submitted.The device was manufactured in may 17, 2018.

• Brand Name: CARTRIDGE
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): BAXTER HEALTHCARE - TIJUANA BAJA; tijuana baja california
• MDR Report Key: 7828227
• MDR Text Key: 118889002
• Report Number: 8030638-2018-00018
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 07332414007836
• UDI-Public: (01)07332414007836
• Combination Product (y/n): N
• PMA/PMN Number: K070414
• 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: 04/15/2021
• Device Catalogue Number: 101025
• Device Lot Number: 1000193298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/29/2018
• Distributor Facility Aware Date: 08/06/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/29/2018
• Date Manufacturer Received: 09/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NORMAL SALINE; PHOENIX MACHINE; REVACLEAR
• Patient Outcome(s): Hospitalization
• Patient Age: 64 YR
• Patient Weight: 100