MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA RENAL THERAPY GROUP COMBI SET TRUE FLOW; HEMODIALYSIS BLOOD TUBING

Device Problem Disconnection (1171)

Patient Problem Exsanguination (1841)

Event Date 12/02/2019

Event Type  Death  

Event Description

Hemodialysis pt attended regularly scheduled dialysis treatment.Pre vs bp 113/71, pulse 71, tempt 95.At approx 1334 dialysis initiated via right central venous catheter.The venous bloodline was connected to the patient's venous catheter port utilizing a hemaclip and the arterial blood line was connected to patient's arterial catheter port.At approx 1406 bp 96/65, pulse 67, blood flow rate 350.At approx 1424 the blood lines were reversed and the venous blood line was connected to the patient's arterial port utilizing a hemaclip and the arterial bloodline was connected to the patient's venous catheter port.At approx 1440 the venous machine pressure alarmed, the patient was found with the venous blood line and an attached hemoclip to the venous bloodline disconnected from the patient's arterial catheter port.The patient was gasping for air and became unresponsive; 911 and cpr initiated.Patient was pronounced deceased at approx 1530.

• Brand Name: COMBI SET TRUE FLOW
• Type of Device: HEMODIALYSIS BLOOD TUBING
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA RENAL THERAPY GROUP ; waltham MA 02451
• MDR Report Key: 9476646
• MDR Text Key: 171559665
• Report Number: 9476646
• 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: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/12/2019
• Distributor Facility Aware Date: 12/02/2019
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 12/12/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 72 YR
• Patient Weight: 71