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

Lot Number 528995

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The distributor reported that during a procedure involving the medivators hf 1200 renaflo ii hemofilter, a filter leak occurred resulting in a procedure delay.The reported filter leak resulted in an approximately 100ml volume of patient blood loss.The procedure was completed successfully.No additional reports of malfunction or injury were reported.

Manufacturer Narrative

The reported hemofilter subject of the event is not available to be returned for evaluation.The reported product is indicated for single use and was exchanged upon detection of the filter leak.A review of manufacturing records indicates that the reported filter met all pre-release specifications regarding sterility, bacterial endotoxin testing, biocompatibility, product integrity and dimensions.The reported event did not cause or contribute to any serious injury or deterioration of health and is not expected to lead to serious injury if the event were to recur.Medivators will continue to monitor for similar events to ensure the product continues to perform as expected.

• Brand Name: RENAFLO II HEMOFILTER
• Type of Device: 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: 14415339
• MDR Text Key: 291849028
• Report Number: 2150060-2022-00026
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K923312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/16/2022

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
• Device Operator: Health Professional
• Device Lot Number: 528995
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/21/2022
• Initial Date FDA Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1