MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PHOENIX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	103453
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an external fluid leak was observed originating from the blood leak detector housing of a phoenix machine during hemodialysis therapy.No alarms were generated by the machine at the time of the reported leakage event.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
E1: initial reporter information: (b)(6).The device was not received for evaluation; however, the device was evaluated on site by a baxter qualified technician.During visual inspection, it was observed the blood leak detector (bld) tube disconnection resulted in the leakage event.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.The reported condition was verified.The bld housing was replaced with a new one and the machine was returned back in service without any other problem.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PHOENIX
• 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 - MEDOLLA MODENA MONITORS; via modenese, 66; medolla modena 41036 ; IT 41036
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 20467489
• Report Number: 9616240-2024-00016
• Device Sequence Number: 7228332
• Product Code: KDI
• UDI-Device Identifier: 07332414042035
• UDI-Public: 07332414042035
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K070643
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/16/2024

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 Catalogue Number: 103453
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NI.
• Patient Sex: Unknown