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

Lot Number C314-KIT

Device Problems Improper or Incorrect Procedure or Method (2017); Failure to Disconnect (2541)

Patient Problem Reaction (2414)

Event Date 06/04/2014

Event Type  Injury  

Event Description

Customer (physician) contacted cse to report a regular ecp patient that had a severe citrate reaction.Patient complained of feeling cold during the return phase of a single-needle treatment.The customer reported that the patients leg muscles became flaccid.Customer stated they gave the patient calcium and the patient is okay and is stable.No prime alarms occurred and no kinks or leaks are visible in the kit.Customer used acd-a anticoagulant at a 8:1 ratio, which is normal for the patient.Customer verified the saline and a/c bags were properly spiked and the volumes of anticoagulant and saline were within the expected range after prime.Customer stated that around 800ml whole blood processed they ended the treatment and noticed a big "jelly clot" in the centrifuge bowl that is not related to the patients platelet count.This clot was noticed when they were manually returning the volume back to the patient.Update (b)(6) 2014: patient is stable and back to normal, customer explained that the patient did lose consciousness for a brief moment, at which point the treatment was stopped.The patient reported that her legs felt heavy and it felt ike the bed was sucking her in.She also reported feeling cold, then hot and very shaky.The customer treated the patient with iv calcium using the return port on the cellex patient tubing at the default flow rate of 50ml/min.The customer infused the calcium during a return phase, with the return bag volume threshold set at 100ml.The customer left the syringe of calcium on the return port of the cellex return tubing while the instrument ws collecting whole blood from the patient.Update (b)(6) 2014: to clarify, the operator error that was committed was setting the return rate to 50ml/min, thereby allowing the return bag contents (acd-a) to be given to the patient at that rate.This influx caused a citrate reaction to occur.The customer then proceeded to treat the citrate reaction with calcium.The calcium was given through the port on the patient return line and was left attached during the collection phase.The syringe of calcium should have been disconnected during the collection phase to prevent the calcium from being drawn into the centrifuge bowl within the procedural thereby causing clot formation.These two operator errors were self-identified by the customer.As a result, the customer site initiated a revision of their patient care procedures and policies at the facility to ensure these types of operator errors do not occur in the future.Service order (b)(4) was dispatched for inspection of the instrument.The customer submitted photos and videos for investigation.The kit and smart card were to be returned but have not been received to date.If these items are returned, a supplemental report will be filed at that time.

Manufacturer Narrative

A review of lot c314 was conducted.There were no non-conformances associated with this lot.The lot met release requirements.Trends have been reviewed for this complaint category and no trends have been detected for clot observed nor for adverse reaction related to citrate.Service order (b)(4) completed.Service engineer pulled the pump heads for inspection.The pump heads were all set low and the collect head was rubbing, with visible signs of wear.Service engineer adjusted the pump head heights, calibrated the pumps and performed system checkout procedure.A photo analysis was conducted for this complaint.The photo shows the semi-solid blood mass in the upper half of the centrifuge bowl and a return bag, confirming the clotting.However, there is no evidence that the instrument did not function as intended.There was a citrate reaction that occurred which was due to operator error.The operator had increased the level of citrate flow to the patient thereby causing the reaction.Since medical intervention was necessary, this case is considered serious and related to treatment, as this happened during treatment.Acda is not labeled for treatment use.If not given, this reaction would not have occurred.Refer to nc7398 for late reporting.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 baily ave; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 east, suite 140; bridgewater, NJ 08807
• MDR Report Key: 4060432
• MDR Text Key: 4731523
• Report Number: 2523595-2014-00221
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P680003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2016
• Device Lot Number: C314-KIT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/04/2014
• Initial Date FDA Received: 08/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 72