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	Cardiac Arrest (1762)
Date of Event	09/24/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Blood loss was confirmed as a result of the filter leak; however, the estimated volume of blood loss is not known.The full medical history for the patient subject of the event was not disclosed to medivators.However, it was reported that the patient had pre-existing conditions, including renal failure, and was in the icu at the time of the hemofiltration procedure.The reported filter subject of the leak is not able to be returned for evaluation.A batch record review was performed which indicated that the batches of filters and fibers for the reported filter lot met all specifications prior to release.No nonconformities were identified during the manufacturing, sterilization and endotoxin testing, and a 100% visual inspection for leak testing was performed without exception.The investigation of this event remains in progress.A follow-up report will be submitted if additional information is obtained.
Event or Problem Description
(b)(4), a distributor of medivators hemofilters, reported that during a hemofiltration procedure involving the medivators hf1200 hemofilter, a filter leak occurred.A second filter was prepped to be exchanged in order to continue the procedure.During the preparation of the second filter, the patient expired.

• 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: 13181365
• Report Number: 2150060-2022-00003
• Device Sequence Number: 4258117
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/05/2026
• Device Model Number: 93024-132
• Device Lot Number: 481877
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2021
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown