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U.S. Department of Health and Human Services

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

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MEDIVATORS, INC. RENAFLO II HEMOFILTER HIGH PERMEABILITY DIALYSIS SYSTEM Back to Search Results
Lot Number 528995
Device Problem Fluid 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.
 
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Brand NameRENAFLO II HEMOFILTER
Type of DeviceHIGH 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 Key14415339
MDR Text Key291849028
Report Number2150060-2022-00026
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K923312
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received05/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number528995
Was Device Available for Evaluation? No
Date Manufacturer Received04/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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