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	Hypersensitivity/Allergic reaction (1907)
Date of Event	12/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The medical history for the patient subject of the event, including known allergies or pre-existing conditions, was not disclosed to medivators.The reported filter subject of the leak is not able to be returned for evaluation.A batch record review was performed which confirmed that the fiber batch and raw materials for the finished filter met all specifications prior to release of the product.No nonconformities were identified in the manufacturing, construction, sterilization or endotoxin testing of the reported filter and the reported filter lot passed 100% leak testing at inspection.The reported hemofilter construction is designed to meet all biocompatibility requirements of iso 10993-4 for blood interactions.No serious injury or deterioration of health was reported to have occurred as a result of the event.Medivators will continue to monitor for similar events to ensure the product continues to perform as expected.
Event or Problem Description
Nikkiso, a distributor of medivators hemofilters, reported that during a hemofiltration procedure involving the medivators hf1200 hemofilter, a filter leak occurred.A patient blood loss of approximately 100ml was reported.The patient was additionally reported to have developed "allergic-like" symptoms including chills, palpitation and sweating.The filter subject of the event was exchanged, and all symptoms were resolved.The procedure was completed with no additional patient consequences reported.

• Brand Name: RENAFLO II HEMOFILTER
• Common Device Name: HIGH PERMEABILITY DIALYSIS SYSTEM
• Manufacturer (Section D): MEDIVATORS, INC.; 14605 28th avenue n; plymouth MN 55447
• Manufacturer (Section G): MEDIVATORS, INC.; 14605 28th avenue n; plymouth MN 55447
• Manufacturer Contact: daniel davy ; 9800 59th avenue n; plymouth, MN 55442 ; 4403927453
• MDR Report Key: 13177417
• Report Number: 2150060-2022-00002
• Device Sequence Number: 4665468
• 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): 01/06/2022

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 Expiration Date: 03/03/2026
• Device Model Number: 93024-132
• Device Lot Number: 488050
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2021
• Initial Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown