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	11/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The user reported that while using the medivators hf-1200, a patient lost approximately 200cc 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.The reported event did not cause or contribute any serious injury or deterioration of health.This event could potentially lead to serious injury if it were to recur.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, a patient lost approximately 200cc 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 no additional medical intervention was sought.

• 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: 10953653
• Report Number: 2150060-2020-00018
• Device Sequence Number: 3217066
• 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: Non-Healthcare Professional
• Type of Report: Initial

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: 422540
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 12/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other