MAUDE Adverse Event Report: GAMBRO RENAL PRODUCTS SA CARTRIDGE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGULATION VALVE

Catalog Number 101025

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Loss Of Pulse (2562)

Event Date 10/15/2014

Event Type  Injury  

Event Description

A pt was undergoing a dialysis treatment on a phoenix machine, cartridge blood tubing set and bicart.Shortly after treatment started, the pt became responsive without a pulse or respirations.Cpr was initiated and the pt was successfully resuscitated.The pt was transferred to the hosp and admitted for further assessment.The phoenix machine was inspected and found to be operating within mfr's spec.The disposables were discarded.(b)(4).

• Brand Name: CARTRIDGE
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGULATION VALVE
• Manufacturer (Section D): GAMBRO RENAL PRODUCTS SA; blvd pacifico no 10014; 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: 4297021
• MDR Text Key: 5194460
• Report Number: 2087532-2014-00041
• Device Sequence Number: 1
• Product Code: FJK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/17/2014,11/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2014
• 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: 11/14/2014
• Distributor Facility Aware Date: 10/17/2014
• Event Location: Other
• Date Report to Manufacturer: 10/17/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BICART,; FRESENIUS F160; PHOENIX MACHINE,
• Patient Outcome(s): Hospitalization
• Patient Age: 83 YR