MAUDE Adverse Event Report: MEDIVATORS INC RENAFLO II HEMOFILTER; HIGH PERMEABILITY DIALYSIS SYSTEM

Model Number	HF 400
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Steris is not the manufacturer of the renaflo ii hemofilter subject of the reported event.Steris notified the manufacturer, evoqua, of the reported event to internally investigate and evaluate for reportability in accordance with 21 cfr part 803.It should be noted that steris is submitting a medical device report (mdr) solely due to the receipt of the user facility medwatch report which is in accordance with our policies and procedures.No additional issues have been reported.
Event or Problem Description
The user facility reported via medwatch report #mw5117414 that during a patient procedure involving the 400 renaflo ii hemofilter, a filter leak occurred.No report of injury or procedure delay.

• Brand Name: RENAFLO II HEMOFILTER
• Common Device Name: HIGH PERMEABILITY DIALYSIS SYSTEM
• Manufacturer (Section D): MEDIVATORS INC; 14605 28th avenue n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS INC; 14605 28th avenue n; minneapolis MN 55447
• Manufacturer Contact: daniel davy ; 14605 28th ave north; minneapolis, MN 55447
• MDR Report Key: 17127608
• Report Number: 2150060-2023-00033
• Device Sequence Number: 18000685
• Product Code: KDI
• UDI-Device Identifier: 00677964000065
• UDI-Public: 00677964000065
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2023

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 Model Number: HF 400
• Device Lot Number: 558091
• 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: 05/16/2023
• Initial Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2022
• 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