MAUDE Adverse Event Report: GAMBRO RENAL PRODUCTS, INC. BLOOD CARTRIDGE SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Lot Number 1000114257

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 08/20/2015

Event Type  malfunction  

Event Description

Patient was on hemodialysis.Blood leaked from area of tego cap connection with luer lock on the venous return flow.Rn noticed blood on patient and in bed.Stopped dialysis and changed out blood set cartridge and tego cap.

• Brand Name: BLOOD CARTRIDGE SET
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): GAMBRO RENAL PRODUCTS, INC.; 9540 maroon cir fl 4; englewood, CO 80112
• MDR Report Key: 5044669
• MDR Text Key: 24663631
• Report Number: 5044669
• 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: Other
• Report Date: 08/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 03/31/2018
• Device Lot Number: 1000114257
• Other Device ID Number: 101025/07332414004836
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/24/2015
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 77 YR