• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

THERAKOS, INC. THERAKOS XTS PHOTOPHERESIS SYSTEM Back to Search Results
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).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key4360434
MDR Text Key19347500
Report Number2523595-2014-00334
Device Sequence Number1
Product Code LNR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P680003
Number of Events Reported1
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 Number10705030100016
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/01/2014
Initial Date FDA Received12/19/2014
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 Number1
Patient Outcome(s) Required Intervention;
Patient Age45 YR
Patient Weight54
-
-