MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA DIALYZER F160NRE

Model Number F160NRE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Dyspnea (1816); Dyspnea (1816); Nausea (1970); Nausea (1970)

Event Date 11/04/2019

Event Type  Death  

Event Description

Pt attended first hemodialysis treatment in dialysis facility.Pt arrived alert and oriented.Pre bp 163/101, pulse 66, temp 97.At approx 1725 hemodialysis initiated via chest central venous catheter.Within approx 5 mins pt complained of difficulty breathing, nausea, feeling hot, face became flushed.Pt reported not feeling right.Pt became unresponsive.Cpr and 911 initiated.Dialysis was terminated, blood was not returned.Pt transferred to hosp.Pt expired.See scanned page.

• Brand Name: DIALYZER F160NRE
• Type of Device: DIALYZER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; 920 winter st.; waltham MA 02451
• MDR Report Key: 9328726
• MDR Text Key: 241260973
• Report Number: 9328726
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/12/2019,11/13/2019

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: F160NRE
• Device Lot Number: 19JU06023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/13/2019
• Distributor Facility Aware Date: 11/04/2019
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/13/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Death
• Patient Age: 58 YR
• Patient Weight: 70