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

Lot Number	934301A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Death (1802)
Date of Event	04/22/2019
Type of Reportable Event	Death
Additional 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 or Problem 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 or Problem 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.
Additional 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.

• Brand Name: RENAFLO II HEMOFILTER
• Common Device Name: HIGH PERMEABILITY DIALYSIS SYSTEM
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 8632573
• Report Number: 2150060-2019-00045
• Device Sequence Number: 1936111
• Product Code: KDI
• UDI-Device Identifier: 00677964000089
• UDI-Public: 00677964000089
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K923312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2023
• Device Lot Number: 934301A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/22/2019
• Supplement Date Received by Manufacturer: 07/03/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 07/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 63 YR