MAUDE Adverse Event Report: THERAKOS INC THERAKOS CELLEX PHOTOPHERESIS SYSTEM; CELEX ECP SYSTEM

Model Number 6661

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 12/19/2013

Event Type  Death  

Event Description

The customer reported a pt death.Name of complainant: same as reporter.Customer called to report a pt expiration that occurred sometime in the early morning hours of (b)(6) 2013.The customer stated they do not believe the pt death is related to the ecp treatment which was performed almost 32 hours prior to death.Clinical services requested more information from the customer.The customer stated that they would call back with more information.No product was returned by the customer for investigation.

Manufacturer Narrative

A review of lot file b334 was performed.There were no nonconformances or alarms associated with this event type reported for this lot.This lot met all release requirements a review of complaints received for lot b334 was performed.There no other reports of death to date for this lot.This assessment is based on the information available at the time of the investigation.The reporter stated that she does not believe there was a relationship between the exp treatment and the pt death.The cause of the death was requested and unk by the reporter.Despite numerous follow up attempts to gather more information from the customer, no response nor additional information has been received to date.A follow up medwatch report will be filed if/when any additional information is provided by the customer.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELEX ECP SYSTEM
• Manufacturer (Section D): THERAKOS INC; bridgewater NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey ave; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 east; ste 140; bridgewater, NJ 08807 ; 9083675452
• MDR Report Key: 3553152
• MDR Text Key: 4054978
• Report Number: 2523595-2014-00018
• 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: 12/19/2013

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: 09/01/2015
• Device Model Number: 6661
• Device Lot Number: B334/375 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2013
• Initial Date FDA Received: 01/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: THE PT WAS ON CONTINUOUS CVVH,ALONG WITH A VARIETY; OF OTHER THERAPIES SUCH AS RESPIRATORY THERAPY.
• Patient Outcome(s): Death
• Patient Age: 4 YR
• Patient Weight: 20