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

Model Number GAMBRO CARTRIDGE EXT DIALYZER LINE

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 06/02/2017

Event Type  malfunction  

Event Description

A patient was undergoing a dialysis treatment utilizing a cartridge bloodline.Soon after the treatment start, the nurse noticed a minimal external blood loss caused by a breakage in the arterial cartridge.The patient did not sustain any injury in connection with the reported event.No medical intervention was necessary.The blood contained in the extracorporeal circuit was returned to the patient.No additional clinical information was provided.

• 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 (Section G): GAMBRO RENAL PRODUCTS S.A. DE C.V.; blvd. pacifico no. 10014; parque industrial pacifico; tijuana ; MX
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6678316
• MDR Text Key: 78907006
• Report Number: 8030638-2017-00015
• 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: company representative,foreig
• Type of Report: Initial
• Report Date: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2018
• Device Model Number: GAMBRO CARTRIDGE EXT DIALYZER LINE
• Device Catalogue Number: 103401
• Device Lot Number: 1000163396
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other