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 EXT. PATIENT LINES + INFUSION

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 02/15/2017

Event Type  malfunction  

Event Description

A patient was undergoing a dialysis treatment utilizing a cartridge bloodline.Soon after the patient connection, the nurse noted a minimal blood loss caused by a small cut at the level of the pump segment of the bloodline.The patient did not sustain any injury in connection with the reported event.No medical intervention was necessary.No additional clinical information has been 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: 6583359
• MDR Text Key: 75776691
• Report Number: 8030638-2017-00014
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K070414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2017
• Device Model Number: CARTRIDGE EXT. PATIENT LINES + INFUSION
• Device Catalogue Number: 114599
• Device Lot Number: 1000151070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2017
• 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