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

Lot Number NOT PROVIDED

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

Patient Problem Collapse (2416)

Event Type  Injury  

Manufacturer Narrative

System was used for treatment.No information regarding the lot number was provided; therefore, a review of the lot trending could not be conducted.The uvadex lot number was not provided.However, a review of all uvadex lots manufactured since january 2013 was performed.No trends or nonconformances related to the complaint were noted.Trends were reviewed.No trend was detected for other adverse event (collapse).The 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 the specific product met specification.There was no specific patient information provided by the customer.Therakos has made several attempts to contact the customer for additional information.Since it is known that a patient collapsed and the customer stated they did not use blood prime protocol (for patient of approximately 10kg), there is a probability that medical intervention was required to address a possible fluid balance issue.Out of an abundance of caution, this case will be reported as an mdr.If any additional information is received, this case will be reopened and processed accordingly.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted through the capa/continuous improvement process.(b)(4).Device not returned.

Event Description

Customer reported, in a series of emails with another customer (see below), that two of their patients had collapsed during the treatment.Date of awareness (b)(6) 2015 - date of event: unknown.The customer stated in her email from (b)(6) 2015 that 2 patients collapsed during their treatment - 2 adverse event case records have been opened (b)(4) therakos' clinical services specialist tried to contact the reporter to gather further information over the phone but customer was out of the office and could not be reached until the following week.Updated 16 nov 2015: customer has been called but responsible physician is not at work today.Updated 17 nov 2015: customer could not be reached by phone.Call capture form (to gather additional information) was sent to the customer via email attachment.No further information was able to be obtained from the customer despite multiple follow-up attempts by therakos.Email summary: sent: (b)(6) 2015 20:41.Subject: ecp for < 10 kg.Dear xxxx, how are you? remember we talked about children < 10 kg for ecp in double needle technique.We wonder why the 2 patients from ulm we did around 10 kg both "collapsed" during treatment.Do your nurses give intermittent saline boluses? what is the starting hematocrit? we would be grateful for some advice, xxxxx" end of the email.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC; west chester PA
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 baily ave; buffalo NY 14211
• Manufacturer Contact: dianna inguanzo ; 10 north high street; suite 300; west chester, PA 19380
• MDR Report Key: 5268480
• MDR Text Key: 32739033
• Report Number: 2523595-2015-00297
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: 10705030100009
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Physician
• Type of Report: Initial
• Report Date: 11/12/2015

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: No Information
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2015
• Initial Date FDA Received: 12/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention