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

Lot Number C312-KIT

Device Problems Leak/Splash (1354); Split (2537); Device Displays Incorrect Message (2591)

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

Event Date 05/07/2014

Event Type  malfunction  

Event Description

Customer called to report drive tube blood leak during treatment procedure, at 1302 ml whole blood processed.Dnm.Peripheral access.Css asked if anyone was exposed to the blood/fluids due to the leak.Customer stated no one was exposed to blood/fluid as it was contained within the centrifuge.Css asked if there were any other alarms, customer stated they had an air detected alarm at the start of the procedure.They were able to reset the alarm and continue with the procedure.Css asked if the drive tube was broken.Customer stated the drive tube is still intact but there is a split in the tube.Css asked if patient was alright, customer stated patient is stable.Service order (b)(4) was dispatched.No product was returned for investigation.

Manufacturer Narrative

Batch record review of lot c312 was conducted.There were no non conformances related to this lot.Lot met release requirements.Trends have been reviewed for this complaint category and a trend has been detected.Capa (b)(4) has already been initiated to investigate this type of events.Service order (b)(4) completed: service engineer completed clean up, replaced the centrifuge leak detector strip and replaced gas shocks; performed system check out and passed.The assessment is based on info available at the time of the investigation.No product was returned for investigation at the time of this report; therefore, it could not be determined if the product met specification based solely on the info provided by the customer.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• 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
• MDR Report Key: 3905790
• MDR Text Key: 4678664
• Report Number: 2523595-2014-00150
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• 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: 05/07/2014

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: 03/01/2016
• Device Lot Number: C312-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/07/2014
• Initial Date FDA Received: 05/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• 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 Age: 46 YR
• Patient Weight: 36