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

Catalog Number 103402

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2020

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 an external blood leak (volume not specified) was observed from the arterial port of a cartridge set during dialysis treatment.This was observed on approximately 16-17 patients.It was reported the bloodline disconnected at the arterial med port and a low arterial pressure alarm was triggered.The bllo pump was reported to have stopped due to low arterial pressure alarm and the arterial chamber was filled with air.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

B5: it was reported during follow up that the breakage occurred at the injection port of the arterial line.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Additional information was received indicating a breakage at the injection port of the arterial line.The cause was undermined.A nonconformance has been opened to address this issue.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: 10174501
• MDR Text Key: 198343798
• Report Number: 8030638-2020-00009
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 07332414046835
• UDI-Public: (01)07332414046835
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2022
• Device Catalogue Number: 103402
• Device Lot Number: 1000223694
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/25/2020
• Initial Date FDA Received: 06/19/2020
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1