MAUDE Adverse Event Report: FRESENIOUS MEDICAL CARE N.A. CUSTOM COMBI SET

Catalog Number 03-2722-9

Device Problem Air Leak (1008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/27/2014

Event Type  malfunction  

Event Description

A hemodialysis inpatient user facility reported during initiation, lots of bubbles were visible in the line.Clinic coordinator stated they primed with saline and everything looked good, did recirculation and were ready to do treatment.As soon as the blood hit the blood pump, air bubbles were visible in the line.Clinic coordinator stated that they there was no impact to the patient and treatment was continued with a new tubing set.Nurse stated there were no defects seen on the lines.They changed out the lines to a different serial number and the issue was resolved.Sample has not been returned to the manufacturer.

Manufacturer Narrative

The plant investigation has not yet been completed.A follow up report will be filed upon completion of the investigation.

• Brand Name: CUSTOM COMBI SET
• Manufacturer (Section D): FRESENIOUS MEDICAL CARE N.A.; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT; parque industrial reynosa; cd, reynosa, tamaulipas ; MX
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter street; waltham, MA 02451 ; 8006621237
• MDR Report Key: 3969470
• MDR Text Key: 19716840
• Report Number: 8030665-2014-00521
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2017
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 14CR01146
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• 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: HEMODIALYSIS MACHINE