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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 934301A
Device Problem Insufficient Information (3190)
Patient Problem Death (1802)
Event Date 04/22/2019
Event Type  Death  
Manufacturer Narrative
(b)(4), distributor of medivators hf 1200 hemofilters in (b)(4), reported a patient expired while the hemofilter was in use. During treatment, it was reported a fiber leak occurred during hemofiltration of the patient. The time at which the leak occurred during the procedure was not disclosed. Further along in the procedure, the patient's condition deteriorated, they coded, and they were unable to be resuscitated. No information was provided regarding the cause of death. Medivators attempted to follow up with no success. Patient's prior health condition is unknown. The unit was not returned for additional investigation by medivators quality assurance. Medivators remains in close contact with (b)(4). This is a (b)(6) region-specific event. There have been no recent complaints of hemofilter leaks reported from the u. S. There are no other reports of patient death connected with medivators hemofilter products. This complaint will continue to be monitored in the medivators complaint handling system.
 
Event Description
(b)(4), distributor of medivators hf 1200 hemofilters in (b)(4), reported a patient expired while the hemofilter was in use. During treatment, it was reported a fiber leak occurred during hemofiltration of the patient. The time at which the leak occurred during the procedure was not disclosed. Further along in the procedure, the patient's condition deteriorated, they coded, and they were unable to be resuscitated. No information was provided regarding the cause of death.
 
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Brand NameRENAFLO II HEMOFILTER
Type of DeviceHIGH PERMEABILITY DIALYSIS SYSTEM
Manufacturer (Section D)
MEDIVATORS INC.
14605 28th ave n
minneapolis MN 55447
Manufacturer (Section G)
MEDIVATORS INC.
14605 28th ave n
minneapolis MN 55447
Manufacturer Contact
hannah shrader
14605 28th ave n
minneapolis, MN 55447
7635596863
MDR Report Key8632573
MDR Text Key145792704
Report Number2150060-2019-00045
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,user facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 07/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2019
Is this an Adverse Event Report? Yes
Device Operator
Device Lot Number934301A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/03/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/13/2019
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: 05/22/2019 Patient Sequence Number: 1
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