MAUDE Adverse Event Report: HARMAC MEDICAL PRODUCTS THERAKOS XTS PHOTOPHERESIS SYSTEM

Lot Number	B707 - KIT
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/17/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This system was used for treatment.Kit lot b707 was reviewed.There were no non-conformances.This lot met all 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 category centrifuge bowl leak/break, bowl cover alarm or system error f183: centrifuge speed too slow.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.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).
Event or Problem Description
Customer called to report f183 alarm during 3rd cycle, customer stated the thumb screw was tightly screwed down.Clinical services specialist (css) advised the customer to power the instrument off, release the bowl vacuum, and verify the centrifuge chamber was adequately greased.Customer stated he did not see any grease.Css advised the customer to grease the centrifuge chuck and to continue to grease their xts instrument(s) every two weeks.Customer confirmed the centrifuge bowl was able to rotate and move easily before placing back into the centrifuge chamber.Css advised the customer to power the instrument back on and verify the bowl had a vacuum seal before closing and screwing the centrifuge lid.Customer resumed the treatment and a bowl cover alarm occurred, css advised the customer to screw the thumbscrew down tighter, customer did as instructed and resumed the patient treatment with a flow rate of 19ml/min.Customer stated they would call back if further assistance was required.Customer called back on (b)(6) 2016 to report that the top of the bowl leaked at the start of cycle 3.Customer reported that no blood got into the instrument, so service will not be required.The procedure was aborted.Patient was reported stable.
Additional Manufacturer Narrative
Additional information, not included in initial report: trends were reviewed for complaint category centrifuge bowl leak/break, bowl cover alarm or system error f183: centrifuge speed too slow.No trend was detected for any of these categories.However, a corrective and preventive action was initiated for complaint category centrifuge bowl leak/break.(b)(4).Device not returned.

• Brand Name: THERAKOS XTS PHOTOPHERESIS SYSTEM
• Common Device Name: XTS
• Manufacturer (Section D): HARMAC MEDICAL PRODUCTS; 2201 baily ave; buffalo NY 14211
• MDR Report Key: 5505518
• Report Number: 2523595-2016-00065
• Device Sequence Number: 397945
• Product Code: LNR
• UDI-Device Identifier: 10705030100016
• UDI-Public: 10705030100016
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 02/17/2016

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: 03/01/2018
• Device Lot Number: B707 - KIT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2016
• Supplement Report FDA Received Date: 03/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Weight: 75