MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE OPTIFLUX; HEMODIALYSIS DIALYZER

Lot Number 15BU06016

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2015

Event Type  malfunction  

• Brand Name: OPTIFLUX
• Type of Device: HEMODIALYSIS DIALYZER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE; 920 winter street; waltham, MA 02451
• MDR Report Key: 4976090
• Report Number: 4976090
• Device Sequence Number: 1
• Product Code: JQQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 07/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: 15BU06016
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/29/2015
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/06/2015
• Patient Sequence Number: 0
• Patient Age: 47 YR