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

Model Number HF 1200

Device Problem Break (1069)

Patient Problem Blood Loss (2597)

Event Date 04/28/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that while a facility was using the medivators hf 1200, a patient lost approximately 100ml of blood.It was reported that there was no harm to the patient.The patient did not experience any symptoms as a result of the blood loss and no additional medical intervention was sought.The unit was not returned for analysis.Based on photos and videos provided, the complaint of a blood filter leak was confirmed.Medivators remains in close contact with the customer and continued investigation is underway.Medivators will continue to monitor for similar events to ensure the product continues to perform as expected.

Event Description

It was reported that while a facility was using the medivators hf 1200, a patient lost approximately 100ml of blood.It was reported that there was no harm to the patient.The patient did not experience any symptoms as a result of the blood loss and no additional medical intervention was sought.

• Brand Name: RENAFLO II HEMOFILTER
• Type of Device: HIGH PERMEABILITY DIALYSIS SYSTEM,
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th ave n; plymouth, mn
• Manufacturer (Section G): MEDIVATORS INC.; 14605 28th ave n; plymouth, mn
• Manufacturer Contact: lauren johnson ; 9800 59th ave n; plymouth, mn
• MDR Report Key: 10096012
• MDR Text Key: 196313324
• Report Number: 2150060-2020-00012
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00677964000089
• UDI-Public: 00677964000089
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K923312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HF 1200
• Device Lot Number: 436600
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other