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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that there was an external blood leak at the junction of the heparin line and the arterial chamber of a cartridge extended dialyzer line.This event occurred at the beginning of treatment.The blood was not returned to the patient and the patient lost approximately 300ml of blood; however, there was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information: h3, h4, h6 and h10.H10: the actual device was not available.However a picture and 8 retention samples were provided.A visual inspection and a leak test of the 8 retention samples was performed and they met the quality acceptance criteria.The reported condition was not verified.A visual inspection of the picture could not verify the reported condition.The most likely cause could be attributable to the manufacturing process, if during the assembling, excess of solvent was dispensed and heparin line got macerated.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
• Common Device Name: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11197071
• Report Number: 8030638-2020-00021
• Device Sequence Number: 677496
• Product Code: FJK
• UDI-Device Identifier: 07332414046835
• UDI-Public: (01)07332414046835
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K070414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2021

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: 06/15/2022
• Device Catalogue Number: 103402
• Device Lot Number: 1000232233
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 01/19/2021
• Supplement Report FDA Received Date: 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NI.