MAUDE Adverse Event Report: THERAKOS, INC. THERAKOS CELLEX SYSTEM

Lot Number C316 - KIT

Device Problems Component Falling (1105); Leak/Splash (1354); Device Contamination with Body Fluid (2317); Device Displays Incorrect Message (2591)

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

Event Date 06/10/2014

Event Type  malfunction  

Manufacturer Narrative

A review of lot c316 was conducted and there were no nonconformances associated with this lot.The lot met release requirements.Trends were reviewed for this complaint categories involved in this complaint and no trend were detected.However, capa's (b)(4) were initiated to further investigate pressure dome issues.The assessment is based on info available at the time of the investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the info provided by the customer.(b)(4).

Event Description

Customer reported a pressure dome leak during the return phase of the treatment procedure.The centrifuge had stopped during the return phase of the procedure when the collect pressure dome came off and blood leaked onto the instrument.The instrument was operating in single needle mode with vortex port access.A 690 ml whole blood processed.Customer reported that no one was exposed to blood or body fluids when the leak occurred.The treatment was aborted with no return of blood to the pt.Customer stated there were a few return pressure alarms during the treatment, which were cleared by flushing the line to continue with the return phase.Customer stated there were no occlusions or clotting throughout the kit.Pt was reported to be in stable condition.No product was returned for investigation.

• Brand Name: THERAKOS CELLEX SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 baily ave.; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 east, suite 140; bridgewater, NJ 08807
• MDR Report Key: 3983390
• MDR Text Key: 16591634
• Report Number: 2523595-2014-00182
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P680003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2016
• Device Lot Number: C316 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2014
• Initial Date FDA Received: 07/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• 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
• Patient Weight: 61