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

Model Number	HF 1200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	04/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that while a facility was using the medivators hf 1200, a patient lost approximately 100ml 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.The unit was not returned for analysis.Based on photos and videos provided, the complaint of a blood filter leak was confirmed.Medivators remains in close contact with the customer and continued investigation is underway.Medivators will continue to monitor for similar events to ensure the product continues to perform as expected.
Event or Problem Description
It was reported that while a facility was using the medivators hf 1200, a patient lost approximately 100ml 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 INC.; 14605 28th ave n; plymouth, mn
• MDR Report Key: 10140996
• Report Number: 2150060-2020-00014
• Device Sequence Number: 2163438
• 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
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2020

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 1200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 06/10/2020
• 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