MAUDE Adverse Event Report: GAMBRO RENAL PRODUCTS S. A. DE C. V. CARTRIDGE

Catalog Number 101025

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 01/29/2015

Event Type  Death  

Event Description

A chronic dialysis pt with end stage renal disease was admitted to the emergency room with chest pain.According to the nurse manager the pt had missed a previously scheduled dialysis treatment.The pt was sent to the hospitals' inpatient dialysis unit for a dialysis treatment.When he arrived on the unit, he was awake, alert, and oriented with stable vital signs.During the dialysis treatment, the pt had a cardiac arrhythmia, a run of ventricular tachycardia and he became unresponsive.The dialysis treatment was stopped and resuscitation efforts were unsuccessful and the pt expired.The cause of death was reported to be cardiac arrest.The nurse manager stated there were not any concerns with the equipment and the dialysis treatment had been uneventful until the cardiac arrest.Mfr ref # 8030638-2015-00001.

• Brand Name: CARTRIDGE
• Manufacturer (Section D): GAMBRO RENAL PRODUCTS S. A. DE C. V.; tijuana ; MX
• Manufacturer (Section G): GAMBRO RENAL PRODUCTS, INC.; 14143 denver west parkway; suite 400; lakewood CO 80401
• Manufacturer Contact: 14143 denver west parkway; suite 400; lakewood, CO 80401
• MDR Report Key: 4562084
• MDR Text Key: 18662425
• Report Number: 2087532-2015-00015
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2015

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 Catalogue Number: 101025
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/27/2015
• Distributor Facility Aware Date: 01/30/2015
• Event Location: Hospital
• Date Report to Manufacturer: 02/27/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/02/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death