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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiopulmonary Arrest (1765)

Event Date 04/09/2014

Event Type  Injury  

Event Description

Limited information has been provided for this event other than the patient had a cardiac history and experienced an episode during treatment that resulted in hospitalization.The clinician at the hospital states that this incident was not product related.The phoenix machine was inspected and determined to be operating within specification.The cartridge blood line was not available for inspection and the the bicart was discarded and not available for inspection.

Manufacturer Narrative

The blood tubing set involved in this incident was not available for investigation and the lot number could not be provided by the facility.

• 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: ramon ruiz ; blvd. pacifico no. 10014; parque industrial pacifico; tijuana ; MX ; 6646266700
• MDR Report Key: 3781963
• MDR Text Key: 18547661
• Report Number: 8030638-2014-00006
• 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: 04/30/2014

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
• Device Lot Number: NOT PROVIDED
• 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: 04/30/2014
• Distributor Facility Aware Date: 04/09/2014
• Event Location: Dialysis Center
• Date Report to Manufacturer: 04/09/2014
• Initial Date Manufacturer Received: 04/09/2014
• Initial Date FDA Received: 04/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PHOENIX SN: (B)(4), BICART
• Patient Outcome(s): Hospitalization