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

Catalog Number 114614

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2021

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 after 45 minutes into treatment using a cartridge sn blood line and an innova machine, an air detection alarm was generated.The air was reportedly related to a problem with the connection between the bloodline and the catheter (exact attachment problem was not reported).The treatment was ended without the extracorporeal blood return.There was no patient injury or medical intervention associated with this event.There was no patient involvement.

Manufacturer Narrative

Additional information: h3, h6 and h10.H10: the actual device was not available; however, a photo and (b)(4) retention samples were received and visually inspected.Air bubbles were observed in the arterial chamber and in the lines of the provided picture.The video observed a connection issue between the catheter and the blue rotating luer connector.The (b)(4) retained samples were visually and functionally inspected and were found within specification.The reported condition was verified.The cause could not be determined.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: 11314990
• MDR Text Key: 231417977
• Report Number: 8030638-2021-00002
• 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: 02/11/2021
• 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 CATHETER; INNOVA MACHINE; ARROW VECTOR FLOW CATHETER.; INNOVA MACHINE.