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

Lot Number C351/129-KIT

Device Problems Fluid/Blood Leak (1250); Device Contamination with Body Fluid (2317); Device Displays Incorrect Message (2591)

Patient Problem Blood Loss (2597)

Event Date 12/15/2014

Event Type  malfunction  

Event Description

The customer called to report a blood leak in the centrifuge chamber.The customer stated that the leak occurred during the purging air phase of the treatment.The patient's access was immediately clamped off and the treatment was aborted.The customer stated that they calculated an approximate blood loss of 250ml.The patient was reported to be in stable condition.During the treatment, the patient was given 10,000 units of heparin in a 500ml bag of normal saline set at a 8:1 a/c ratio.The patient's original platelet count was 239,00 and post blood leak the patient's platelet count was 225,000.The customer explained that they were currently preparing to treat the patient using a different instrument.The customer explained they would not visibly tell where the leak came from, since the bowl and the drive tube looked intact.Service order (b)(4) was generated.An update on (b)(4) 2014 states that the customer explained that on (b)(6) 2014 that we were responding to an alarm, and upon looking at the instrument, they noticed there was blood in the centrifuge chamber.The customer stated that they immediately clamped the patient tubings and turned the instrument off.The customer was not sure what alarm had occurred during treatment.The customer will return the used procedural kit and smart card for investigation.

Manufacturer Narrative

A review of lot c351 was conducted.There were no nonconformances associated with this lot.The lot met release requirements.Trends were reviewed for complaint category, alarm #7: blood leak (centrifuge chamber).No trend was detected for this complaint category.No capa was initiated for complaint category , alarm #7: blood leak (centrifuge chamber).Service order, (b)(4), feedback: the service technician cleaned the centrifuge and the centrifuge door.He then performed the system checkout.No further action required.This assessment is based on information available at the time of the investigation.The customer has agreed to return the kit and smart card for evaluation; however, at this time the manufacturer has yet to receive the kit or the smart card.Once the kit and smart card have been received by the manufacturer, analysis of the returned kit and smart card will begin.A supplemental report will be filed when the analysis 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 east,ste. 100; bridgewater, NJ 08807
• MDR Report Key: 4373671
• MDR Text Key: 5285779
• Report Number: 2523595-2014-00337
• 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: 12/15/2014

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: 10/01/2016
• Device Lot Number: C351/129-KIT
• Other Device ID Number: 10705030100009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2014
• Initial Date FDA Received: 12/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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: 66