MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 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 Dyspnea (1816)

Event Date 03/24/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during dialysis treatment with a phoenix machine, non- baxter dialyzer and a gambro cartridge set, a patient experienced shortness of breath.It was reported during a line change upon ¿rinse back¿, pink dialysate was observed in the tubing.The cause of the pink dialysate was unknown.Treatment was discontinued with returning the extracorporeal blood to the patient.The patient began to experience shortness of breath.It was reported the oxygen saturation did not fall below 90%.Treatment was not reported.The patient¿s outcome was reported as ¿symptoms did improve¿.No additional information is available.

Manufacturer Narrative

The device (gambro cartridge set) was not returned and the lot number is unknown; therefore, a device analysis could not be completed.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 CORPORATION; deerfield IL
• MDR Report Key: 9973753
• MDR Text Key: 189754500
• Report Number: 8030638-2020-00002
• 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
• Report Date: 04/17/2020,05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• 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: ASKU
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/17/2020
• Distributor Facility Aware Date: 03/25/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/17/2020
• Date Manufacturer Received: 05/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NON BAXTER NIPRO DIALYZER; PHOENIX MACHINE
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR