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

Lot Number	866947A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	04/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Nikkiso, distributor of hemofilters in (b)(4), reported that while a facility was using the medivators hf 1200, a patient lost approximately 120ml of blood.It was reported the 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 by medivators qa.Based on photos provided, the complaint of a blood filter leak was confirmed.Medivators remains in close contact with nikkiso.Continued investigation is underway.This is a china region-specific event.There have been no recent complaints of hemofilter leaks from the u.S.This complaint will continue to be monitored in the medivators complaint handling system.
Event or Problem Description
Nikkiso, distributor of hemofilters in (b)(4), reported that while a facility was using the medivators hf 1200, a patient lost approximately 120ml of blood.It was reported the 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; minneapolis MN 55447
• MDR Report Key: 8604555
• Report Number: 2150060-2019-00042
• Device Sequence Number: 3236076
• 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): 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2022
• Device Lot Number: 866947A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2019
• Initial Report FDA Received Date: 05/13/2019
• 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