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

Catalog Number 114614

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2020

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 during treatment using a cartridge sn blood line, an external blood leak was observed at the venous luer lock.(described as micro leak).The amount of blood loss was not reported.The extracorporeal blood was returned to the patient.There was no patient injury or medical intervention associated with this event.There was no patient involvement.

Manufacturer Narrative

H10: the actual device was not available; however, a video, a drawing and eight retained samples were received.The drawing provided was visually inspected and the arterial rotating luer connector was marked as the component involved instead of the venous rotating luer connector.The video observed a connection issue between the catheter and the rotating luer connector.The reported condition was verified.Eight retained samples were received and were visually and functionally inspected.The retention samples were found to be within specification.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.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: 11322556
• MDR Text Key: 263477678
• Report Number: 8030638-2021-00003
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): Y
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 114614
• Device Lot Number: 1000250125
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARROW VECTOR FLOW