MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE HOLDINGS, INC. COMBISET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Model Number 03-2622-3

Device Problems Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 10/08/2021

Event Type  malfunction  

Event Description

Hemodialysis treatment initiated without difficulty.Rn noted blood dripping from bloodline, noted small tear in bloodline.Treatment stopped and restarted with new equipment.

• Brand Name: COMBISET
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): FRESENIUS MEDICAL CARE HOLDINGS, INC.; 920 winter street; waltham MA 02451
• MDR Report Key: 12646551
• MDR Text Key: 276874872
• Report Number: 12646551
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/14/2021

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 Model Number: 03-2622-3
• Device Catalogue Number: 03-2622-3
• Device Lot Number: 21ER01075
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/14/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21900 DA
• Patient Weight: 83