MAUDE Adverse Event Report: GAMBRO RENAL PRODUCTS S.A. DE C.V. BLVD. PACIFICO NO. 10014 CARTRIDGE

Catalog Number 101025

Device Problem Insufficient Information (3190)

Patient Problems Seizures, Absence (2261); Loss of consciousness (2418)

Event Date 02/02/2015

Event Type  Injury  

Event Description

A dci dialysis clinic contacted gambro to have a phoenix machine inspected following a patient seizure.It is dci's corporate policy not to release patient information however, the nurse manager stated that approximately 2.5 hours into treatment, the patient experienced a seizure and then lost consciousness.The patient was admitted to the emergency room where he was treated for a critically low blood sugar.The patient improved and was sent home from the emergency room.The disposables were discarded and not available for inspection.The machine was inspected and found to be operating within manufacturer's specification.Reference mfr # 8030638-2015-00002.

• Brand Name: CARTRIDGE
• Manufacturer (Section D): GAMBRO RENAL PRODUCTS S.A. DE C.V. BLVD. PACIFICO NO. 10014; 14143 denver west parkway; suite 400; lakewood CO 80401
• 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: 4586263
• MDR Text Key: 21243189
• Report Number: 2087532-2015-00017
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/04/2015

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/04/2015
• Distributor Facility Aware Date: 02/02/2015
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/04/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/09/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PHOENIX, BICART
• Patient Outcome(s): Required Intervention