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 Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Blood Loss (2597)

Event Date 06/20/2016

Event Type  Injury  

Event Description

A patient had a blood loss during a dialysis treatment when the patient reportedly pulled the venous needle from the av fistula.The patient had a cardiac arrest and was successfully resuscitated and transferred to the icu.The patient was transfused with blood.The dialysis nurse manager estimated that the phoenix machine continued to run for a minute at a bfr of 400 ml/min before it alarmed.The phoenix machine was inspected and operating within manufacturer's specification with audible alarms.The machine was returned to service following a simulated patient run.The cartridge blood tubing was discarded and not available for inspection.

• 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: 5797116
• MDR Text Key: 49620409
• Report Number: 8030638-2016-00007
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/14/2016

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: No Information
• Device Model Number: CARTRIDGE
• Device Catalogue Number: 101025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/14/2016
• Distributor Facility Aware Date: 06/21/2016
• Event Location: Dialysis Unit
• Date Report to Manufacturer: 06/21/2016
• Initial Date Manufacturer Received: 06/21/2016
• Initial Date FDA Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: PHOENIX MACHINE
• Patient Outcome(s): Required Intervention