MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION AUTO EFFLUENT ACCESSORY AND EXTENSION; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	115370
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2024
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 while performing continuous renal replacement therapy, a prismax auto effluent bag was leaking at the junction of the bag and the tubing.To resolve this issue, the effluent bag was replaced.There was no report of patient injury or medical intervention associated with this event.No additional information was available.
Additional Manufacturer Narrative
Additional information added to h6 and h11.H11: 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.Should additional relevant information become available, a supplemental report will be submitted.The ¿auto effluent accessory¿ is an optional automatic effluent emptying accessory used with the prismax and intended to eliminate the need to drain or change effluent bags during therapy.The prismax machine is designed with a drip tray at the base of the control unit to collect fluid if a leakage is present; an alarm is generated when the amount of leaked fluid exceeds 50ml.There is no data indicating that the prismax failed in triggering an alarm if the effluent leak exceeded the 50ml limit.There was no patient injury or medical intervention associated with this case.The prismax is designed with leak detection and the reported event does not have the likelihood to cause or contribute to death or serious injury.

• Brand Name: AUTO EFFLUENT ACCESSORY AND EXTENSION
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; carretera sanchez km 18.5; parque industrial itabo, piisa; haina, san cristobal 91000 ; DR 91000
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 19397871
• Report Number: 1416980-2024-02540
• Device Sequence Number: 17881365
• Product Code: KDI
• UDI-Device Identifier: 07332414118914
• UDI-Public: (01)07332414118914
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K163530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2024

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: 09/10/2025
• Device Catalogue Number: 115370
• Device Lot Number: 22I1002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown