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

Catalog Number	103402
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem 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.
Additional 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
• Common Device Name: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10174501
• Report Number: 8030638-2020-00009
• Device Sequence Number: 2625449
• Product Code: FJK
• UDI-Device Identifier: 07332414046835
• UDI-Public: (01)07332414046835
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K070414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 04/15/2022
• Device Catalogue Number: 103402
• Device Lot Number: 1000223694
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/25/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 07/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1