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 Problems Chest Pain (1776); Hemolysis (1886)

Event Date 06/01/2018

Event Type  Injury  

Manufacturer Narrative

A batch review was conducted and there were no deviations found related to the reported condition during the manufacture of this lot.The actual device was not available for evaluation.However, (b)(4) retained samples from the same lot were visually inspected.No deviations or damages were observed during the inspection of the retained samples.The retained samples were also measured with no anomalies observed.The reported condition was not verified.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 experienced hemolysis manifested by increase in blood pressure and chest pain, approximately thirty minutes into treatment.Treatment was interrupted and the patient was sent to the emergency room.There was no medical intervention reported with this event.The patient outcome was not reported.No additional information is available.The machine was inspected by bio-med and found to be working fine.No alarms generated, arterial and venous pressures looked fine, no issues with tmp or uf rate.The blood tubing (p/n 101025), lot#: 1000189381 sample was discarded and not available for return.Customer did not noticed any kinks or visible defect on the blood lines.Customer is trying to understand what could caused the hemolysis.Patient is stable, but currently in the hospital.

• 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
• Manufacturer (Section G): BAXTER HEALTHCARE - TIJUANA BAJA; blvd pacifico 10014; parque industrial pacifico; tijuana baja california CP 22 643; MX CP 22643
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7655965
• MDR Text Key: 112935073
• Report Number: 8030638-2018-00008
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 07332414007836
• UDI-Public: (01)07332414007836
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2021
• Device Catalogue Number: 101025
• Device Lot Number: 1000189381
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/05/2018
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: PHOENIX DIALYSIS MACHINE
• Patient Outcome(s): Hospitalization