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

Model Number HF 1200

Device Problem Break (1069)

Patient Problem Blood Loss (2597)

Event Date 11/16/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4), distributor of hemofilters in (b)(4), reported that while a facility was using the medivators hf 1200, a patient lost approximately 200 ml 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 by medivators qa.Based on photos provided, the complaint of a blood filter leak was confirmed.Medivators remains in close contact with (b)(4).Continued investigation is underway.This is a (b)(4) region-specific event.There have been no recent complaints of hemofilter leaks reported from the u.S.This complaint will continue to be monitored in the medivators complaint handling system.

Event Description

(b)(4), distributor of hemofilters in (b)(4), reported that while a facility was using the medivators hf 1200, a patient lost approximately 200 ml 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; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: sadie martin ; 14605 28th ave n; minneapolis, MN 55447
• MDR Report Key: 8160645
• MDR Text Key: 130223187
• Report Number: 2150060-2018-00076
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00677964000089
• UDI-Public: 00677964000089
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2023
• Device Model Number: HF 1200
• Device Lot Number: 908762
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/16/2018
• Initial Date FDA Received: 12/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2018
• 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