MAUDE Adverse Event Report: MEDIVATORS INC 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	10/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user reported that while using the medivators hf1200 hemofilter, a blood leak occurred and the patient lost approximately 100 ml of blood.It was reported that there was no harm to the patient.The patient did not experience any symptoms as a result of the blood loss and the reported event did not cause or contribute to any serious injury or deterioration of health.The reported filter was not returned and is not available for investigation.A batch review was performed and no anomalies were noted with the reported filter lot.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 hf 1200 hemofilter, a fiber leak occurred during a patient procedure resulting in approximately 100ml of patient blood loss.It was reported that there was no harm to the patient.The patient did not experience any symptom as a result of the blood loss and no additional medical intervention was sought.

• Brand Name: RENAFLO II HEMOFILTER
• Common Device Name: HIGH PERMEABILITY DIALYSIS SYSTEM
• Manufacturer (Section D): MEDIVATORS INC; 14605 28th ave n; plymouth MN 55447
• MDR Report Key: 12681645
• Report Number: 2150060-2021-00023
• Device Sequence Number: 11802590
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/22/2021

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: 458287
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 10/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1