MAUDE Adverse Event Report: REYNOSA MANUFACTURING COMBI SET

Catalog Number 03*2622-3

Device Problems Disconnection (1171); Fluid/Blood Leak (1250); Material Separation (1562)

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

Event Date 04/08/2014

Event Type  malfunction  

Event Description

A hemodialysis in patient user facility has reported that at the end of treatment, a leak occurred.The leak was visually observed.Where the saline line is attached, the line separated and fell out.This occurred at completion of treatment.The biomed stated that there was no blood leak and the patient was disconnected at the time.Patient's blood had been returned.Patient had no adverse effects and did not require any medical intervention.Tech realized the saline line was disconnected and there was a saline leak after the patient was disconnected.

Manufacturer Narrative

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

• Brand Name: COMBI SET
• Manufacturer (Section D): REYNOSA MANUFACTURING; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT; brecha e99 sur; parque; industrial reynos, bldg. ii; cd, reynosa, tamps 8878 0; MX 88780
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter street; waltham, MA 02451 ; 8006621237
• MDR Report Key: 3969782
• MDR Text Key: 4628664
• Report Number: 8030665-2014-00348
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2016
• Device Catalogue Number: 03*2622-3
• Device Lot Number: 13PR01321
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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