MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA COMBISET TRUE FLOW SERIES; COMBISET BLOOD LINES

Catalog Number 03-2722-9

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/23/2021

Event Type  malfunction  

Event Description

Venous end of combiset blood line broke off inside of venous fistula needle when disconnected for pt to pause dialysis treatment to go to the bathroom.This prohibited reconnecting to the fistula needle to continue / complete the dialysis treatment.

• Brand Name: COMBISET TRUE FLOW SERIES
• Type of Device: COMBISET BLOOD LINES
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA ; waltham MA 02451
• MDR Report Key: 12161663
• MDR Text Key: 261643916
• Report Number: 12161663
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 20LR01138
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/23/2021
• Event Location: Outpatient Treatment Facility
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Weight: 66