MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA, REYNOSA PLANT FRESENIUS COMBI SET 2008

Model Number COMBI SET

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

Patient Problem Blood Loss (2597)

Event Date 01/07/2012

Event Type  malfunction  

Event Description

Tech called fresenius technical support and states the venous chamber/plastic mesh allowed a blood clot to get through.They were able to catch it before it re-entered patient.

Manufacturer Narrative

A product investigation was performed for this device.During visual analysis of the device no defect was found in the filter, therefore the symptom reported was not confirmed.A review of the device history record was performed.There were no unexpected variances adjustments or comments noted in the device records.A medical review was performed on the available information and the cause of the event is undetermined.This is a retrospective mdr being submitted by fresenius medical care as a remediation action committed to fda regarding all potential adverse events received between 21 march 2011 to 11 march 2013.

• Brand Name: FRESENIUS COMBI SET 2008
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA, REYNOSA PLANT
• Manufacturer (Section G): REYNOSA PLANT; parque ind. reynosa sur, brecha e-99; apartado postal 3326; reynosa, tamps 8878 0; MX 88780
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4047833
• MDR Text Key: 4813559
• Report Number: 8030665-2014-00649
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/09/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: COMBI SET
• Device Catalogue Number: 03-2622-3
• Device Lot Number: 11NR01005
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/18/2012
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/09/2012
• Initial Date FDA Received: 08/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other