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

Catalog Number	109536
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
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 following thirty to forty minutes of treatment, an external blood leak originated from the ¿bottom of the loop where the line reconnects to the set' of a gambro cart access site prime.Treatment was restarted with a new machine and set of disposables after treatment was stopped for approximately ten (10) to fifteen (15) minutes and was completed without an issue.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information: a3, d9, h3, h6 and h10.H10: the actual device and 8 retained samples was received for evaluation.A visual inspection showed a gap in the connection of the venous dialyzer connector.The reported condition was verified.The cause is most probably assembly related.Evaluation of the eight retained samples met the quality acceptance criteria.The cause was attributable to the manufacturing and assembling process.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: 12264361
• Report Number: 8030638-2021-00015
• Device Sequence Number: 12012448
• Product Code: FJK
• UDI-Device Identifier: 07332414085216
• UDI-Public: (01)07332414085216
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2021

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: Other
• Device Expiration Date: 01/15/2024
• Device Catalogue Number: 109536
• Device Lot Number: 1000287840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 09/02/2021
• 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: PHOENIX 115V US MACHINE