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

Model Number CARTRIDGE

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 10/01/2016

Event Type  malfunction  

Event Description

A patient in (b)(6) was undergoing a dialysis treatment which included a cartridge blood line.Reportedly, there was an external blood loss between the heparin line and the syringe.No additional information has been provided.The date of this event is unknown therefore, the date of the event is an estimated date.

• 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: 6064325
• MDR Text Key: 58817442
• Report Number: 8030638-2016-00014
• 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
• Type of Report: Initial
• Report Date: 10/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2019
• Device Model Number: CARTRIDGE
• Device Catalogue Number: 103401
• Device Lot Number: 1000143882
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/04/2016
• Initial Date FDA Received: 10/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2016
• 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