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 Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/10/2020

Event Type  malfunction  

Event Description

Upon initiating of treatment blood started leaking from the heparin pigtail line.When leaking was identified the piece of tubing was lifted at the pigtail area on the line and the entire tubing disconnected from the main line of the dialysis tubing.Blood started coming out at the connector.No patient harm noted.

• 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: 10379303
• MDR Text Key: 202049772
• Report Number: 10379303
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/21/2020,07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 20AR01093
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/21/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18615 DA