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

Model Number	93024-132
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility reported that while using the medivators hf1200 hemofilter, after 1 hour of use, a fiber leak occurred which resulted in a patient losing approximately 173 ml of blood.It was reported that there was no harm to the patient and the patient did not experience any adverse symptoms as a result of the blood loss.No medical interventions were reported to be required as a result of the blood loss.The reported event did not cause or contribute to any serious injury or deterioration of health.Medivators will continue to monitor for similar events to ensure the product continues to perform as expected.
Event or Problem Description
The user facility reported that while using the medivators hf1200 hemofilter, a fiber leak occurred which resulted in approximately 173 ml of patient blood loss.There was no harm to the patient reported.No medical intervention was sought and no adverse patient symptoms were reported.

• Brand Name: RENAFLO II HEMOFILTER
• Common Device Name: HIGH PERMEABILITY DIALYSIS SYSTEM
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; plymouth MN 55447
• MDR Report Key: 12526709
• Report Number: 2150060-2021-00018
• Device Sequence Number: 3322780
• Product Code: KDI
• UDI-Device Identifier: 00677964000089
• UDI-Public: 00677964000089
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K923312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/24/2021

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 Model Number: 93024-132
• Device Lot Number: 488052
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2021
• Initial Report FDA Received Date: 09/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1