MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE HOLDINGS, INC. F160 OPTIFLUX ULTRA DIALYZER; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 0500416E

Device Problems Fluid/Blood Leak (1250); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/06/2022

Event Type  malfunction  

Event Description

Dialyzer blood leak, treatment stopped, blood not returned, discarded approximately 200 mls, reset with new set.Machine tested and found to be appropriate for service.No harm to patient during malfunction of device.Event reached patient, no harm/no detectable harm.

• Brand Name: F160 OPTIFLUX ULTRA DIALYZER
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): FRESENIUS MEDICAL CARE HOLDINGS, INC.; 920 winter street; waltham MA 02451
• MDR Report Key: 14944293
• MDR Text Key: 295414520
• Report Number: 14944293
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 0500416E
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/23/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/07/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1