MAUDE Adverse Event Report: REYNOSA MANUFACTURING CUSTOM COMBI SET W/SPLIT SEPTUM

Catalog Number 03-2621-5

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Blood Loss (2597)

Event Date 01/16/2014

Event Type  Injury  

Event Description

A hemodialysis inpatient user facility has reported that during treatment, a blood leak occurred.The leak was visually observed and the machine alarmed.Estimated blood loss was 100cc's and the patient was unable to get blood back.Clinical manager stated the tubing separated from the blue round connector approximately six inches from where the patient is connected.Patient was symptomatic.Blood pressure dropped to 54/30, and heart rate dropped to 34.Patient then coded.Patient had a poor catheter access site, but was reconnected and received normal saline.Vitals increased.Sample has not been returned to the manufacture.

Manufacturer Narrative

Medical records have been requested and have not been received by the manufacturer to date.At the conclusion of the investigation, a supplemental report will be filed with the results of the clinical and plant investigations.

• Brand Name: CUSTOM COMBI SET W/SPLIT SEPTUM
• Manufacturer (Section D): REYNOSA MANUFACTURING; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT; parque ind. reynosa; reynosa, tamaulipas CP 8 8780; MX CP 88780
• Manufacturer Contact: jennifer nabukenya ; 920 winter street; waltham, MA 02451 ; 8006621237
• MDR Report Key: 3659566
• MDR Text Key: 17384975
• Report Number: 8030665-2014-00167
• 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: 01/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2016
• Device Catalogue Number: 03-2621-5
• Device Lot Number: 13JR01012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 93 YR