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

Lot Number C710-KIT

Device Problem Insufficient Information (3190)

Patient Problems Fever (1858); Vomiting (2144)

Event Date 06/03/2014

Event Type  Injury  

Event Description

Customer reported that the pt started to vomit after pt had eaten lunch.Customer did not relate the vomiting to the treatment because the pt had often problems with nausea and vomiting after meal.Treatment was in 2nd cycle.Customer and responsible physician decide to end the treatment without buffy coat collection.Pretreatment temperature: 36,9 deg c, temperature in the evening: 38 deg c.Pt started on antibiotics for suspected infection.Css called back the customer to get info about the suspected infection.Blood culture was done on (b)(6) 2014.Customer could not say what kind of infection.Css tried to contact the customer to get more info about suspected infection.Customer was not on place.Css try next day to contact the customer.Updated (b)(6) 2014: css called customer and asked about info about suspected infection.Customer stated that the pt is still in hematology dept and she had no possibility to get info about the suspected infection.Customer did not return product for investigation.

Manufacturer Narrative

Batch record review of lot c710 was conducted.There were no non conformance related to this lot.Let met release requirements.Trends have been reviewed for this complaint category and no trend has been detected for these type of events.The assessment is based on info available at the time of the investigation.Vomiting and fever associated with this case are probable due to the pt's underlying condition.Pt did have an infection and had vomiting symptom prior to treatment.Even though the symptoms are unrelated to the procedure, the pt was hospitalized for the infection and medical intervention of antibiotics were given, this case is assessed as serious and unrelated.(b)(4).

• Brand Name: THERAKOS XTS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey ave; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 east; ste 140; bridgewater, NJ 08807
• MDR Report Key: 3951903
• MDR Text Key: 4627916
• Report Number: 2523595-2014-00186
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• 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: 02/01/2019
• Device Lot Number: C710-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/04/2014
• Initial Date FDA Received: 07/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• 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 Weight: 63