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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Itching Sensation (1943)

Event Date 12/01/2014

Event Type  Injury  

Event Description

The customer called to report that the patient has been complaining about itching in mouth and ears during 4th and 5th phase of treatment.The customer stated there are no visible rash or hives on the patient.The customer stated that the patient did not complain of itching from the first treatment on the therakos instrument.The customer reported that the patient has had a total of about 100 ecp treatment procedures and has only recently started to complain of the itching.The customer stated that the patient claims the itching stops after the procedure is completed.The customer stated that the itching does not begin at the start of the procedure; instead, it starts towards the end of the procedure.The customer stated there has been no change to any of the patient's medications.The customer stated they have been giving the patient benadryl to treat the symptoms.The customer stated they do not believe this reaction is related to uvadex.The customer stated the itching occurs prior to uvadex infusion.The customer stated they are suspecting a possible reaction to ethylene oxide.The customer wanted to know if there was a way to remove the ethylene oxide from the kit by doing a second prime.The patient was reported to be in stable condition.A therakos clinical educator was contacted to further discuss this issue with the customer.A clinical services specialist called the customer back on (b)(6) 2014, to discuss customer's question regarding ethylene oxide in the disposable kits.The customer reported that he thought they might be able to remove some of the ethylene oxide from the kit before connecting the patient to the kit.The customer's idea was to start cycle one by substituting a bag of saline in place of the patient, then to end cycle one early before the buffy collect starts, returning the volume from the kit to the substitute bag of saline, then to disconnect the substitute saline bag and connect the patient to restart cycle one.The clinical services specialist advised the customer that therakos has no protocol for the process he was considering, so therakos cannot recommend it.No kit lot number was provided.No product was returned for evaluation and no service order was generated.

Manufacturer Narrative

A lot number was not provided; therefore, no batch record review could be performed.Trends were reviewed for complaint category, allergic reaction.No trend was detected.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 specifications 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 through the capa/continuous improvement process.(b)(4).

• Brand Name: THERAKOS XTS PHOTOPHERESIS SYSTEM
• 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, ste 140; bridgewater, NJ 08807
• MDR Report Key: 4360434
• MDR Text Key: 19347500
• Report Number: 2523595-2014-00334
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/01/2014

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
• Other Device ID Number: 10705030100016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2014
• Initial Date FDA Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 45 YR
• Patient Weight: 54