MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE FRESENIUS MEDICAL CARE CAMBI SET BLOODLINES; DIALYSIS BLOODLINES

Catalog Number 03-2722-9C

Device Problems Disconnection (1171); No Fail-Safe Mechanism (2990)

Patient Problems Cardiac Arrest (1762); Exsanguination (1841)

Event Date 12/04/2023

Event Type  Death  

Event Description

At approx 1342 hemodialysis treatment was initiated via a central venous catheter (cvc) at a prescribed blood flow rate of 400.A hemaclip secured the connection between the red hub of the central venous catheter and the venous blood line.A safety check was performed at 1403.At that time, the patient was alert and speaking with a staff member.Vital signs at that time were blood pressure 167/107 and pulse 76.At 1430, a staff member went to the patient to perform a routine safety check.It was noted that patient had repositioned blanket and blanket was covering the blood line to catheter connection.The staff member removed the blanket and observed blood escaping from the central venous catheter to blood line connection.Blood in the extracorporeal circuit was returned immediately.The patient was pulseless and cpr was started and ems was called at 1432.Ems arrived at 1440 and assumed care of the patient.The patient was taken to (b)(6) emergency department where further intervention was provided.Resuscitation attempts were unsuccessful and the patient passed away at 1524.

• Brand Name: FRESENIUS MEDICAL CARE CAMBI SET BLOODLINES
• Type of Device: DIALYSIS BLOODLINES
• Manufacturer (Section D): FRESENIUS MEDICAL CARE; waltham MA
• MDR Report Key: 18447612
• MDR Text Key: 332152211
• Report Number: 18447612
• Device Sequence Number: 1
• Product Code: FJK
• 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: 12/13/2023,12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 03-2722-9C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/15/2023
• Distributor Facility Aware Date: 12/04/2023
• Event Location: Other
• Date Report to Manufacturer: 12/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTRAL VENOUS CATHETER; FRESENIUS MEDICAL CARE 2008T MACHINE; FRESENIUS MEDICAL CARE GRANUFLO 2.0K, 2.5CA 100 DEXTROSE; FRESENIUS MEDICAL CARE HEMACLIP; FRESENIUS MEDICAL CARE NORMAL SALINE; FRESENIUS MEDICAL CARE OPTIFLUX 180 NRE DIALYZER
• Patient Outcome(s): Death
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 42 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American