MAUDE Adverse Event Report: REYNOSA MFG CUSTOM COMBI SET

Catalog Number 03-2722-9

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/23/2014

Event Type  malfunction  

Event Description

A hemodialysis inpatient user facility reported during treatment, a blood test occurred.Blood was leaking out of the tubing at the heparin line connection one hour into treatment.Estimated blood loss was 200cc's.Pt's had no adverse effects and required no medical intervention.

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): REYNOSA MFG; cd, reynosa, tamps ; MX
• Manufacturer (Section G): REYNOSA PLANT; mike allen 1331; parque industrial reynosa; cd, reynosa, tamps 8878 0; MX 88780
• Manufacturer Contact: jennifer nabukenya ; 920 winter street; waltham, MA 02451 ; 8006621237
• MDR Report Key: 3826220
• MDR Text Key: 4500684
• Report Number: 8030665-2014-00181
• 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: 01/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2016
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 13LR01076
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• 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: FRESENIUS 2008K MACHINE
• Patient Age: 57 YR