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

Catalog Number 114614

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

Patient Problem Hemolysis (1886)

Event Type  Injury  

Manufacturer Narrative

Occurrence date is an unknown date in (b)(6) 2020.(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that at the end of treatment with a single needle blood line, hd cartridge and a non baxter machine, a patient was identified to have sustained a severe hemolysis event and the blood lines upstream and downstream the expansion chamber in the arterial blood line were also observed to be kinked.The patient was admitted to intensive care unit and was reported to be in a critical condition.No additional information is available.

Manufacturer Narrative

Additional information: h3, h6 and h10.H10: the actual device was not available; however, six photos of the sample were received and visually inspected.The transport tubes of the arterial dialyzer line were observed to be kinked.The reported condition was verified.Eight retained samples were received and visually inspected.Sample #2, #3, #5, #6, #7 and #8 did not confirm the reported condition.The venous dialyzer line of sample #1 and #4 were observed to be kinked.The reported condition was verified for samples #1 and #4.The cause was related to packaging.A nonconformance has been opened to address this issue.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: 11149864
• MDR Text Key: 231799023
• Report Number: 8030638-2020-00018
• 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: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: Yes
• 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: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INNOVA MACHINE
• Patient Outcome(s): Other