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 Cardiopulmonary Arrest (1765); Dyspnea (1816); Seizures (2063)

Event Date 02/20/2019

Event Type  Injury  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that within 2-3 minutes after starting treatment with an unknown hd cartridge set, the patient experienced a cardiac episode, seizure like activity, unresponsiveness, pulseless, agonal breathing and the patient¿s face turned blue/purple.Treatment was discontinued.It was reported a code was called and cardiopulmonary resuscitation (cpr) was initiated.A swishing sound was heard during heart auscultation and was advised not to shock via aed device.Oxygen 8l was provided.The patient recovered consciousness and normal breathing resumed.The cause of the events was unknown.It was reported the event started as soon as the blood had passed through the extracorporeal circuit.The extracorporeal blood was not returned to the patient.It was reported the total blood loss was 100 ml.The patient was admitted to hospital for ¿a couple of days with a cardiac workup¿.It was reported the patient received another treatment the same day after hospital admission.At the time of this report, the patient outcome was not reported.No additional information is available.

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.

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

• 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: 8511305
• MDR Text Key: 141913011
• Report Number: 8030638-2019-00003
• Device Sequence Number: 1
• Product Code: FJK
• 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,Followup
• Report Date: 04/16/2019,05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 101025
• Device Lot Number: 1000210314
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/16/2019
• Distributor Facility Aware Date: 04/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/16/2019
• Date Manufacturer Received: 04/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PHOENIX MACHINE; REVACLER 300 DIALYZER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR