MAUDE Adverse Event Report: THERAKOS, INC. THERAKOS UVAR XTS PHOTPHERESIS SYSTEM; UVAR XTS ECP SYSTEM

Model Number 6660

Device Problems Burst Container or Vessel (1074); Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

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

Event Date 01/16/2014

Event Type  malfunction  

Event Description

Customer is reporting a centrifuge bowl leak.Name and function of complaint: same as reporter.Customer reported a bowl explosion during early phase of 1st cycle after 5 minutes.Customer reported that suddenly it gave a big bang and bowl leak alarm was given.When they inspected the centrifuge chamber, they found broken bowl and blood spread everywhere.(b)(4) was dispatched to inspect the instrument.Customer submitted photos for investigation.

Manufacturer Narrative

Batch record review: a review of lot file b721 shows no nonconformance associated with this log.This lot met all release requirements.A review of complaints received for lot b721 was performed.There was one other centrifuge bowl leak reported at the time of the investigation.No trends were detected.Service order (b)(4) feedback: field engineer arrived.Centrifuge chamber was full of blood and the kit was still in system.Cleaned centrifuge inside and outside.Replaced centrifuge covers and drain bag.Centrifuge with test bowl and vacuum checked, then performed checkout procedure.Repairs have returned this instrument to expect operation.Customer submitted photos for investigation.The investigation was still ongoing at the time of the report.Therefore, no root cause could yet be determined.(b)(4).

• Brand Name: THERAKOS UVAR XTS PHOTPHERESIS SYSTEM
• Type of Device: UVAR XTS ECP SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey avenue; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 east suite 140; bridgewater, NJ 08807 ; 9083675452
• MDR Report Key: 3755377
• MDR Text Key: 4471055
• Report Number: 2523595-2014-00056
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P680003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/16/2014

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: 07/01/2018
• Device Model Number: 6660
• Device Lot Number: B721-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2014
• Initial Date FDA Received: 02/11/2014
• 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