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

Model Number 14JR01192

Device Problems Fluid/Blood Leak (1250); Split (2537)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/18/2015

Event Type  malfunction  

Event Description

While pt was receiving hemodialysis treatment, blood was noted on pump and floor.The dialysis treatment was stopped.Pt remained stable.Hemodialysis tubing found to have a split in it.Estimated blood loss 500 cc.Pt kept one additional day for observation.

• Brand Name: FRESENIUS COMBI SET TRUE FLOW
• Type of Device: HEMODIALYSIS BLOOD TUBING SET
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; waltham MA 02451
• MDR Report Key: 4620815
• MDR Text Key: 5575193
• Report Number: 4620815
• Device Sequence Number: 1
• Product Code: LDD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2017
• Device Model Number: 14JR01192
• Device Lot Number: 03-2722-9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/18/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/09/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 54