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

Model Number 103401

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 04/01/2016

Event Type  malfunction  

Event Description

A patient in (b)(6) was undergoing a dialysis treatment which included a cartridge blood line.Reportedly, ten minutes into the dialysis session an external blood leak was observed.Treatment was temporarily stopped and the blood in the extracoporeal circuit was returned to the patient.

• Brand Name: CARTRIDGE
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): GAMBRO RENAL PRODUCTS S.A. DE C.V.; blvd. pacifico no. 10014; parque industrial pacifico; tijuana ; MX
• Manufacturer Contact: luz del sol rodriguez ; blvd. pacifico no. 10014; parque industrial pacifico; tijuana ; MX ; 6646266700
• MDR Report Key: 5642701
• MDR Text Key: 44785374
• Report Number: 8030638-2016-00003
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• PMA/PMN Number: K070414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial
• Report Date: 05/09/2016

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: 103401
• Device Lot Number: 1000128964
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/15/2016
• Initial Date FDA Received: 05/09/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other