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

Lot Number REQUESTED BUT NOT PROVIDED-KIT

Device Problems Insufficient Flow or Under Infusion (2182); Improper Flow or Infusion (2954)

Patient Problems Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Tachycardia (2095)

Event Date 07/29/2016

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.The kit lot number was not provided; therefore, a batch record review could not be performed.Uvadex lot# ae4000 (manufacture date: 07/27/2015 and expiration date 06/30/2018) was reviewed.No trends or nonconformances related to the complaint were noted.Trends were reviewed for complaint categories, hypotension, heart rate increase, and central line infection.No trends were detected for these complaint categories.From a device perspective, there was no known device malfunction.However, since the physicians were not able to rule out ecp as a possible cause for the central line infection and the device may have contributed to the spread of the infection, this case is being reported out of an abundance of caution.The assessment is based on information available at the time of the investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.Adverse event terms: hypotension, tachycardia, and infection.(b)(4).Device not returned to manufacturer.

Event Description

The customer reported that a treatment on (b)(6) 2016, was aborted during the reinfusion phase due to the patient becoming hypotensive and tachycardic.The customer stated that the treatment volume from the extracorporeal photopheresis (ecp) procedure was 130ml, but only 10 mls of this volume was returned to the patient before the treatment was aborted.The customer reported that it was the patient's physician who made the decision to disconnect the patient from the instrument and to abort the procedure.The customer stated that the patient was given 200ml of saline after the procedure.The customer also reported that the patient had an infected/septic line due to aseptic techniques, however it was unclear if the infection occurred prior to or during the ecp treatment.The customer stated that the hospital discovered that the patient's line was septic after a culture, which was performed after the ecp treatment, came back positive.The customer stated that the patient was started on antibiotics later that day.The customer reported that it is unknown when the line became septic or who exactly had been accessing the line (the patient was in picu).The customer stated that the central line had been placed approximately one week prior to the ecp treatment.The kit was not returned for investigation.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC; hampton NJ
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 5919837
• MDR Text Key: 53665821
• Report Number: 2523595-2016-00205
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Lot Number: REQUESTED BUT NOT PROVIDED-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Weight: 11