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

Catalog Number ASKU

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

Patient Problem Cardiopulmonary Arrest (1765)

Event Date 11/25/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during hemodialysis treatment using an unknown hd cartridge blood line, the patient coded.It was reported that an unspecified medical intervention was required however, further details were not reported.The patient was transported to the emergency room and subsequently hospitalized for the event.At the time of this report, the patient outcome was unknown.No additional information is available.

Manufacturer Narrative

Correction: removal of information in section f related to importer - the initial report inadvertently indicated that the report was being submitted as an importer report.This mdr should have been submitted only as a manufacturer report (and not as an importer report).

Manufacturer Narrative

H10: the device 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: 11057256
• MDR Text Key: 223362341
• Report Number: 8030638-2020-00017
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): Y
• PMA/PMN Number: NI
• 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: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/25/2020
• Event Location: Hospital
• Date Manufacturer Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PHOENIX MACHINE; UNKNOWN DIALYZER
• Patient Outcome(s): Hospitalization