MAUDE Adverse Event Report: REYNOSA PLANT CUSTOM COMBI SET

Catalog Number 03-2722-9

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

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

Event Date 10/08/2014

Event Type  malfunction  

Event Description

A hemodialysis inpatient user facility has reported that during treatment, a blood leak occurred.The leak was visually observed.The heparin line separated from the blood line.Test strips were not used to confirm and the machine did not alarm due to leak being external.Estimated blood loss was 300 cc.The pt had no adverse effects and no medical intervention was required.The pt completed treatment with a new set up.Sample available.

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): REYNOSA PLANT; parque; industrial reynosa; reynosa, tamps 8878 0; MX 88780
• Manufacturer Contact: dianne chin ; 920 winter st; waltham, MA 02451-1457 ; 7815699105
• MDR Report Key: 4230715
• MDR Text Key: 5000050
• Report Number: 8030665-2014-00819
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2017
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 14ER01048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/08/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2014
• 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 2008K HEMODIALYSIS MACHINE
• Patient Age: 77 YR