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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
Model Number 93024-132
Device Problem Fluid Leak (1250)
Patient Problem Cardiac Arrest (1762)
Event Date 09/24/2021
Event Type  Death  
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 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.
 
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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 Key13181365
MDR Text Key283384544
Report Number2150060-2022-00003
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 01/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number93024-132
Device Lot Number481877
Was Device Available for Evaluation? No
Date Manufacturer Received12/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/05/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/06/2022 Patient Sequence Number: 1
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