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

Model Number 0500318N

Device Problem Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 01/21/2020

Event Type  malfunction  

Event Description

Patient's dialysis treatment initiated per protocol without issue.A few minutes into treatment blood was noticed leaking around dialyzer.All connections properly in place.Blood seemed to be leaking from the head of the dialyzer.Treatment stopped immediately.Md made aware.Blood not returned to patient.Lines and dialyzer discarded and new system set up and tx resumed without issue.Patient lost 207cc blood.Current hgb 10.Per md recheck hgb next treatment two days later.

• Brand Name: OPTIFLUX®
• 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: 9710993
• MDR Text Key: 179435289
• Report Number: 9710993
• 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: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 0500318N
• Device Lot Number: 19NU01010
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/28/2020
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 32120 DA