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

Catalog Number 101025

Device Problem Insufficient Information (3190)

Patient Problem Hemolysis (1886)

Event Date 03/23/2016

Event Type  Injury  

Event Description

A patient in (b)(6) was undergoing a dialysis session on a phoenix machine and a cartridge blood line.Two hours into treatment the patient developed chills, fever and chest pain.Labs were drawn which revealed hemolysis.According to the nurse, the patient's fistula was difficult to cannulate.An echo of the fistula revealed the fistula was severe stenosis.The nephrologist and nurse practitioner could not determine the cause of the hemolysis.It is their opinion that the hemolysis was likely a result of a kink in the blood line (although no kink in the line was reported) or due to the stenosed fistula.The phoenix machine was inspected and within manufacturer's specification.

• 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: cecilia hernandez ; blvd. pacifico no. 10014; parque industrial pacifico; tijuana ; MX ; 6646266700
• MDR Report Key: 5572473
• MDR Text Key: 42492096
• Report Number: 8030638-2016-00002
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K070414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Hospital Service Technician
• Type of Report: Initial,Followup
• Report Date: 04/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Catalogue Number: 101025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention