MAUDE Adverse Event Report: REYNOSA PLANT CUSTOM COMBI SET

Catalog Number 03-2722-9

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)

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

Event Date 12/17/2014

Event Type  malfunction  

Event Description

A hemodialysis inpatient user facility reported that during treatment, a blood leak occurred.The blood leak was visually observed leaking from the venous tubing at or around the venous port.The pt's estimated blood loss was "2 cups" (473ml) the machine did not alarm.It was reported that there was a possible tear in the tubing or a crack at the cap.The pt was not rinsed back.No adverse effects and no medical intervention was required.The physician was advised on the pt's treatment.The pt completed treatment.It was reported that damage was observed when removing the customer combi set bloodline.The facility reported "seal around venous chamber pig tail was broken".The sample is available for the mfr's eval.

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 PLANT; cd, reynosa, tamps ; MX
• Manufacturer (Section G): REYNOSA PLANT; mike allen 1331 parque industrial; cd, reynosa, tamps 8878 0; MX 88780
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter street; waltham, MA 02451-1457 ; 7916999000
• MDR Report Key: 4436484
• MDR Text Key: 5314524
• Report Number: 8030665-2015-00025
• 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: 12/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2017
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 14NR01141
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2014
• 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: 78 YR
• Patient Weight: 78