MAUDE Adverse Event Report: GAMBRO RENAL PRODUCTS, S.A. DE C.V. CARTRIDGE BLOOD SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Model Number 101025

Device Problems Display or Visual Feedback Problem (1184); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 02/12/2023

Event Type  malfunction  

Event Description

Reported that the patient was initiated on hemodialysis.Within the first 2 minutes of treatment, the phoenix machine began to alarm with blood in dialysate error.Blood was noted to be in the hansen tubing.Treatment stopped and unable to rinse the blood back.Provider notified and treatment was resumed with a new machine and new setup.

• Brand Name: CARTRIDGE BLOOD SET
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): GAMBRO RENAL PRODUCTS, S.A. DE C.V.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 16494864
• MDR Text Key: 310788513
• Report Number: 16494864
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 07332414007836
• UDI-Public: 07332414007836
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101025
• Device Catalogue Number: 101025
• Device Lot Number: 10(MAO12209655 8
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/24/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/07/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29930 DA
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Race: White