MAUDE Adverse Event Report: THERAKOS THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Lot Number E105 - KIT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cellulitis (1768); Hematoma (1884); Unspecified Infection (1930)

Event Date 04/15/2016

Event Type  Injury  

Manufacturer Narrative

System was used for treatment.Kit lot e105 was reviewed.There were no non-conformances related to the complaint.This lot met all release requirements.Uvadex lot # ad8348 was reviewed.No trends or nonconformances related to the complaint were noted.Trends were reviewed for complaint categories cellulitis and infection (infected hematoma) and no trend was detected for either of these categories.This assessment is based on information available at the time of the investigation.No product was returned by the customer for investigation; therefore, it could not be determined if this specific product met specification.Although there was no device malfunction, the patient condition deteriorated post treatment and it is possible the device/treatment was a contributing factor, hence this event has been assessed as reportable.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.(b)(4).

Event Description

Customer reported a (b)(6) female patient with a history of acute graft vs.Host disease of the gut and skin completed 2 days of extracorporeal photopheresis (ecp) on (b)(6) 2016.This was completed without any complications noted.On april 15, they report she developed vasculitis.They report she had and infected hematoma and was an immunosuppressed patient.She was admitted for further treatment.Hematoma evacuated - about 600ml on (b)(6).No permanent damage to a body structure was reported.On follow up the site reported she has recurrence of disease, and she has relapsed relatively early post transplant.Medical is establishing the best treatment for her in terms of treating disease and limiting side effects.She is also treated for the recurrent left leg cellulitis.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS; hampton NJ 08827
• Manufacturer (Section G): THERAKOS; hampton NJ 08827
• Manufacturer Contact: megan vernak ; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 5849141
• MDR Text Key: 51222232
• Report Number: 2523595-2016-00170
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Expiration Date: 01/01/2018
• Device Lot Number: E105 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2016
• Initial Date FDA Received: 08/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2016
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 38 YR
• Patient Weight: 72