MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE SITE: REYNOSA PLANT CUSTOM COMBI SET

Model Number CUSTOM COMBI SET

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Blood Loss (2597)

Event Date 01/07/2013

Event Type  malfunction  

Event Description

It was reported by a user facility of the fmc device that the arterial part of the tubing is not allowing fluid to flow freely and that there could be a blockage.The peritoneal dialysis rn stated there were no kinks in the blood lines and blockages seen, but she thinks the line might be obstructed.There was an ebl of 200 mls because of clotting.No medical intervention needed.No patient ill effects.

Manufacturer Narrative

A case of (b)(6) companion samples were returned for evaluation.The companion samples were visually inspected and found to be acceptable.In addition, all bonds for both, the arterial and venous lines were closely reviewed and found to be properly assembled.During simulated use treatment 2 samples were found to have longer priming times.The analysis confirmed the alleged failure stated in the complaint.The clinical investigation indicates the patient's were asymptomatic and no medical intervention was required.This is a retrospective mdr being submitted by fresenius medical care as a remediation action committed by fda regarding all potential adverse events received between march 21, 2011 to march 11, 2013.

• Brand Name: CUSTOM COMBI SET
• Manufacturer (Section D): FRESENIUS MEDICAL CARE SITE: REYNOSA PLANT
• Manufacturer (Section G): REYNOSA PLANT; parque ind. reynosa sur, brecha e-99; apartado postal #326; reynosa, tamps CP 8 8780; MX CP 88780
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4070944
• MDR Text Key: 16448593
• Report Number: 8030665-2014-00705
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/11/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CUSTOM COMBI SET
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 12PR01895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2013
• 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