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

Lot Number E714-KIT

Device Problems Break (1069); Device Reprocessing Problem (1091); Fluid/Blood Leak (1250); Device Contamination with Body Fluid (2317)

Patient Problem Exposure to Body Fluids (1745)

Event Date 09/27/2016

Event Type  malfunction  

Manufacturer Narrative

The system was used treatment.A batch record review of kit lot e714 was conducted.There were no nonconformances associated with this lot.The lot met release requirements.The uvadex lot number was not provided as it was not administered.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 for complaint categories, centrifuge bowl leak/break and leak centrifuge alarm.No trends were detected for these complaint categories.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.(b)(4).

Event Description

The customer reported a centrifuge bowl leak/break during cycle 5 of a treatment procedure.The customer stated that a leak centrifuge alarm had also occurred.The customer reported that the treatment was aborted.The customer stated that they had forgotten that the patient's blood should not be returned back to the patient in the case of a leak due to a potential sterility issue.The customer reported that they had already manually returned some of the patient's blood in the return bag back to the patient.The customer stated that the patient was in stable condition and that they would call back in case any other issues occur.The customer reported that the treating physician had transfused the patient prior to the treatment with a unit of packed red blood cells in order to increase the patient's hematocrit level.The customer also stated that the patient was given ringer's solution throughout the treatment in order to minimize the negative fluid shift, thus there was no need for any medical intervention.The customer reported that they wanted to know how to open the fluid logic module door so that they could remove the centrifuge bowl.The customer stated that the leak had not run down into the bottom of the centrifuge chamber, however the centrifuge walls were sprinkled with blood.The customer was advised on how to clean instrument.The kit was not returned for investigation as it had already been discarded.

• Brand Name: THERAKOS XTS PHOTOPHERESIS SYSTEM
• Type of Device: XTS
• 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: 6049560
• MDR Text Key: 58519910
• Report Number: 2523595-2016-00231
• Device Sequence Number: 1
• Product Code: LNR
• 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: Nurse
• Type of Report: Initial
• Report Date: 09/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 03/01/2021
• Device Lot Number: E714-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2016
• 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 Age: 14 YR
• Patient Weight: 25