MAUDE Adverse Event Report: REYNOSA PLANT CUSTOM COMBI SET

Catalog Number 03-2742-9

Device Problems Fluid/Blood Leak (1250); Suction Problem (2170)

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

Event Date 11/19/2014

Event Type  malfunction  

Event Description

A hemodialysis inpatient user facility reported that during initiation of treatment a blood leak occurred.The arterial chamber reserve decreased at a rapid rate and there was air in the system.The blood leak was visually observed from the actual blood line.The patient completed treatment following the incident.There was no damage observed when removing the combiset bloodline.The sample is available for the manufacturer's evaluation.

Manufacturer Narrative

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): REYNOSA PLANT; reynosa ; MX
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen 1331 parque industrial; reynosa, tamaulipas CP 8 8780; MX CP 88780
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter st; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4360834
• MDR Text Key: 5112870
• Report Number: 8030665-2014-00919
• 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: 11/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2017
• Device Catalogue Number: 03-2742-9
• Device Lot Number: 14KR01033
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2014
• 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: FRESENIUS 2008T HEMODIALYSIS MACHINE
• Patient Age: 45 YR
• Patient Weight: 82