Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVATORS INC. RENAFLO II HEMOFILTER; HIGH PERMEABILITY DIALYSIS SYSTEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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.
 
Event Description
Based on the initially reported information and additional details provided for this event, it has been confirmed that the patient was septic prior to the hf 1200 hemofiltration procedure.During the procedure, it was reported a fiber leak occurred, indicating that blood was identified as leaking from one or more fibers and was captured within the filter casing.A fiber leak is visually detectable by the operator.The time at which the leak occurred during the procedure was not disclosed.The patient was reported to be near death and the decision was made by the facility and patient's family to send him home where he expired.It was reported that no autopsy was performed.Given the status of the patient being septic prior to the hemofiltration procedure, and the results of the investigation, it is believed that the patient outcome is unlikely to be related to the hf 1200 and/or reported fiber leak.
 
Manufacturer Narrative
Based on the initially reported information and additional details provided for this event, it has been confirmed that the patient was septic prior to the hf 1200 hemofiltration procedure.During the procedure, it was reported a fiber leak occurred, indicating that blood was identified as leaking from one or more fibers and was captured within the filter casing.A fiber leak is visually detectable by the operator.The time at which the leak occurred during the procedure was not disclosed.The patient was reported to be near death and the decision was made by the facility and patient's family to send him home where he expired.It was reported that no autopsy was performed.Given the status of the patient being septic prior to the hemofiltration procedure, and the results of the investigation, it is believed that the patient outcome is unlikely to be related to the hf 1200 and/or reported fiber leak.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
RENAFLO II HEMOFILTER
Type of Device
HIGH PERMEABILITY DIALYSIS SYSTEM
Manufacturer (Section D)
MEDIVATORS INC.
14605 28th ave n
minneapolis MN 55447
MDR Report Key8632573
MDR Text Key145792704
Report Number2150060-2019-00045
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00677964000089
UDI-Public00677964000089
Combination Product (y/n)N
PMA/PMN Number
K923312
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,user facility
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 Health Professional
Device Expiration Date10/31/2023
Device Lot Number934301A
Was Device Available for Evaluation? No
Date Manufacturer Received07/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age63 YR
-
-