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

Lot Number	D748-KIT
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The system was used for treatment.A review of kit lot d748 was performed.There were no non-conformances related to this complaint.This lot met all release requirements.The uvadex lot number was not provided, since uvadex 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 category leak centrifuge alarm and centrifuge bowl leak/break.No trends were identified for these categories analysis of the returned kit is still in progress.A supplemental report will be filed when this analysis is complete.(b)(4).
Event or Problem Description
The customer called to report a blood leak alarm at the end of cycle 2 after drawing had been completed on the xt125 bowl.The customer stated there was no fluid in the centrifuge waste bag, no fluid visible anywhere from the kit and no fluid was felt on the kit.Css advised the customer to abort the treatment and remove the bowl for further inspection.The customer stated the bottom of the bowl is intact and there is no fluid in the centrifuge chamber.Some dried blood was found on the top of the bowl.Customer stated the patient is sleeping with a blood pressure of 144/70.The patient will be given 500ml of normal saline to replace the blood loss.The customer will return the kit for evaluation.
Additional Manufacturer Narrative
The centrifuge bowl associated with the complaint was returned.The return bowl was examined and analysis indicated that there were 4 spots of dried liquid of a very light color on one side of the bowl, below the seal,.Which could be an indication a leak occurred because the bowl seal lifted during the treatment.The likely cause for lifted bowl seal is back pressure in the system due to an occlusion.Examination of the returned bowl found no visible defects or damage in the ceramic rotary seal.Therefore, the root cause could not be determined.A review of the device history record for this lot of bowl found no related issues.(b)(4).

• Brand Name: THERAKOS XTS PHOTOPHERESIS SYSTEM
• Common Device Name: XTS
• Manufacturer (Section D): THERAKOS, INC.; hampton NJ
• MDR Report Key: 5428521
• Report Number: 2523595-2016-00015
• Device Sequence Number: 725630
• Product Code: LNR
• UDI-Device Identifier: 10705030100016
• UDI-Public: 10705030100016
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P860003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2016

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
• Operator of Device: Nurse
• Device Expiration Date: 12/01/2020
• Device Lot Number: D748-KIT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2016
• Supplement Report FDA Received Date: 04/05/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 68