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

Catalog Number 03-2622-3

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Blood Loss (2597)

Event Date 08/25/2014

Event Type  malfunction  

Event Description

A hemodialysis clinic manager (cm) reported the clamp failed on the product during patient treatment.According to the cm, a nurse was preparing to attach a syringe containing medication to the line.The clamp appeared to be closed, but blood leaked out after she took the cap off the line.Ebl was approximately 50ml and no medical intervention was required.The patient continues on hemodialysis.The actual sample was returned for evaluation.

Manufacturer Narrative

The actual device was returned to the manufacturer for physical evaluation and the complaint is not confirmed.One functional inspection was performed to confirm the alleged product problem.During the inspection, it was found that the clamp was working properly.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the batch record review confirmed the labeling, material and process controls were within specification.

• Brand Name: COMBI SET 2008
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT; erika de reynosa, s.a. de c.v.; mike allen 1331, parque industrial reynosa; reynosa, tamaulipas ; MX
• Manufacturer Contact: tanya taft ; 920 winter street; waltham, MA 02451 ; 8006621237
• MDR Report Key: 4138290
• MDR Text Key: 22261388
• Report Number: 8030665-2014-00760
• 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: Other
• Type of Report: Initial
• Report Date: 08/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: 03-2622-3
• Device Lot Number: 14CR01271
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 53 YR