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

Lot Number C347-KIT

Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

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

Event Date 12/16/2014

Event Type  malfunction  

Event Description

Customer called to report a blood leak in the centrifuge chamber during a blood prime procedure.Customer explained the blood prime was completed at approximately 297 ml whole blood processed (wbp) at which point the patient was connected in double needle configuration.The blood leak occurred at approximately 389 ml wbp.The customer then aborted the treatment, the patient was isovolumic at this point and no blood loss occurred.The customer stated that an alarm occurred but she did not know what exact alarm had occurred.Customer stated the patient is currently being treated on a different instrument and is stable.Service order, (b)(4) was dispatched.The customer has elected not to return the kit for investigation.Therakos is attempting to obtain the smart card for investigation.

Manufacturer Narrative

A review of lot c347 was performed.There were no non-conformances associated with this lot.This lot met release requirements.Trends were reviewed for complaint category, alarm #7: blood leak (centrifuge chamber).No trend was detected.No capa was initiated for this complaint category.Service order (b)(4) completed: field engineer cleaned up the blood spill and performed system checkout.No further action required.The assessment is based on information available at the time of the investigation.Therakos is trying to obtain the smart card for evaluation; however, at this time, the manufacturer has not yet received the smart card.A supplemental report will be filed when this evaluation is complete.(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 baily ave.; buffalo NY 14211
• Manufacturer Contact: 440 us route 22, ste. 140; bridgewater, NJ 08807
• MDR Report Key: 4373681
• MDR Text Key: 15905347
• Report Number: 2523595-2014-00342
• 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: 12/16/2014

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: 09/01/2016
• Device Lot Number: C347-KIT
• Other Device ID Number: 10705030100009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2014
• Initial Date FDA Received: 12/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• 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: 2 YR
• Patient Weight: 17