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

Lot Number C755 - KIT

Device Problems Fluid/Blood Leak (1250); Decreased Pump Speed (1500); Device Displays Incorrect Message (2591); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem Blood Loss (2597)

Event Date 12/04/2015

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot c755 was performed.There were no nonconformances related to this complaint.This 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, system error f183: centrifuge speed too slow and centrifuge bowl leak/break.No trends were detected for these complaint categories.Evaluation of the returned kit is still in process at the time of this report.A supplemental report will be filed when this analysis is complete.(b)(4).

Event Description

Customer called to report system error f183: centrifuge speed too slow, during the beginning of cycle 6.Customer stated they have cycled the power without resolution to alarm f183.Customer confirmed the thumbscrew was not wobbly and was tightly screwed.Css advised the customer to unscrew the thumbscrew, open the centrifuge lid, ensure nothing was blocking the lid from re-closing and tightly re-screw the thumbscrew, turn the power back on and resume the treatment.Customer stated another f183 alarm occurred, css advised the customer turn the instrument off again, open the centrifuge lid, press the centrifuge release button, and remove the centrifuge bowl.Customer stated the centrifuge chamber is usually greased monthly, css advised the customer to grease the chamber every two weeks and to ensure adequate grease was present on the bowl chuck seal, customer began to add some grease when they noticed a leak coming from the centrifuge bowl itself.Css advised the customer to abort the treatment.Upon follow-up, the customer stated the patient was stable and no medical intervention was necessary.The customer stated they will calculate the red cell loss and discuss the next steps with the patient's provider.Technical service called customer back on (b)(4) 2015.Customer stated there had not been any blood leak alarms, and no blood was visible in the centrifuge.The customer returned the kit for investigation.

Manufacturer Narrative

The centrifuge bowl and data key were returned for analysis.A review of the data key indicated that several empty a/c and occlusion patient alarms occurred in cycle # 3.This cycle was ended early.In cycle #6, an empty a/c alarm, several occlusion patient alarms and a system error f183: centrifuge speed too slow alarm occurred.The customer cycled power and then two air detected alarms and a bowl vacuum alarm occurred.The centrifuge bowl was examined and dried blood was found on the outside of the bowl near the outside of the pink ring in the bowl seal.The evidence indicated that the leak occurred due to the bowl seal lifting.The likely cause for a bowl seal to lift is backpressure in the system due to an occlusion.The bowl manufacturer also examined the centrifuge bowl and found no visible defects or damage in the bowl's ceramic rotary seal.Therefore, the root cause for the bowl leak could not be determined.All bowls pass a 100% leak and spin cycle test prior to being released from manufacturing.A review of the device history record for this bowl lot found no related issues.Trends were reviewed for complaint categories, empty a/c alarm, occlusion patient alarm, air detected alarms, and bowl vacuum alarm.No trends were detected for these complaint categories.(b)(4).

• Brand Name: THERAKOS XTS PHOTOPHERESIS SYSTEM
• Type of Device: XTS
• Manufacturer (Section D): THERAKOS INC.; west chester PA
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey ave; buffalo NY 14211
• Manufacturer Contact: megan vernak ; 53 frontage road; suite 300; hampton, NJ 08827
• MDR Report Key: 5313402
• MDR Text Key: 34754390
• Report Number: 2523595-2015-00317
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100016
• UDI-Public: 10705030100016
• 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,Followup
• Report Date: 12/04/2015

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
• Device Operator: Nurse
• Device Expiration Date: 10/01/2019
• Device Lot Number: C755 - KIT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2015
• Initial Date FDA Received: 12/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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