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 Blood Loss (2597)

Event Date 01/17/2014

Event Type  Injury  

Event Description

An external blood leak occurred during dialysis treatment.The nurse reported the leak came from the "general vicinity of the top of the dialyzer." the nurse could not identify the location of the external leak.The cartridge blood tubing set and non- gambro dialyzer were discarded prior to being inspected to determined the location of the external leak.There was no adverse event to the patient.A new circuit was set up and the patient finished her scheduled treatment.The phoenix machine was inspected and performed per manufacturer's specifications.

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: 3625173
• MDR Text Key: 4207852
• Report Number: 8030638-2014-00004
• 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: 02/14/2014,01/17/2014

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: 02/14/2014
• Distributor Facility Aware Date: 01/17/2014
• Event Location: Dialysis Center
• Date Report to Manufacturer: 01/17/2014
• Initial Date Manufacturer Received: 01/17/2014
• Initial Date FDA Received: 02/12/2014
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PHOENIX MACHINE SN (B)(4), REXEED 25S DIALYZER.
• Patient Outcome(s): Other