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U.S. Department of Health and Human Services

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

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THERAKOS, INC. THERAKOS XTS PHOTOPHERESIS SYSTEM Back to Search Results
Lot Number B902 - KIT
Device Problems High Test Results (2457); Device Operates Differently Than Expected (2913)
Patient Problems Bacterial Infection (1735); Fever (1858); Unspecified Infection (1930)
Event Date 08/28/2014
Event Type  Injury  
Event Description
Customer had observed fever 39-40 degrees celsius and increased crp values for a patient the night after ecp.Customer wanted to know whether there is literature regarding crp values and ecp.Customer was provided with information from medical affairs including relevant literature.Customer reported that gram-positive cocci were detected in blood cultures and that they concluded that catheter-related sepsis is the cause.The patient was hospitalized after the treatment and was started on iv broad-spectrum antibiotics.This was later changed to staphylex (narrow spectrum antibiotic against common gram-positive organisms).It was reported that the patient would be treated with iv-antibiotics for 14 days and will then go home for two weeks.He will receive ecp again afterwards, with peripheral access.The patient's current condition was reported to be good.
 
Manufacturer Narrative
A review of lot b902 was performed.There were no nonconformances associated with the lot met release requirements.Trends have been reviewed for the relevant complaint categories and no trends were detected for fever, chills, central line infection, or other adverse event.This assessment is based on information available at the time of this report.No product was returned for evaluation; therefore, it could not be determined if this specific product met specifications.The increase in crp is, most likely, related to the sepsis and not directly to ecp.This incident is being reported because hospital admission occurred with medical intervention.
 
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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, suite 140
bridgewater, NJ 08807
MDR Report Key4122369
MDR Text Key21494332
Report Number2523595-2014-00242
Device Sequence Number1
Product Code LNR
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P680003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial
Report Date 08/28/2014
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 Date09/01/2018
Device Lot NumberB902 - KIT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/28/2014
Initial Date FDA Received09/18/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2013
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) Hospitalization; Required Intervention;
Patient Age62 YR
Patient Weight72
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