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

Lot Number C710-KIT

Device Problem Insufficient Information (3190)

Patient Problems Exsanguination (1841); Blood Loss (2597)

Event Date 04/10/2014

Event Type  Injury  

Event Description

Customer reported four system occlusion alarms occurred during cycle 2 elutriation.No kinked lines or blood clots were visible.Customer verified the anticoagulant and saline spikes were connected to the correct bags.Customer delivered two saline boluses to the patient with the instrument successfully.Customer resumed the treatment and another system occlusion alarm occurred.Customer ended cycle 2, and the volume in the bowl and return bag were successfully returned to the patient.Customer resumed treatment again and system occlusion alarm returned.Customer conferred with the attending physician and chose to end the treatment, and start a new treatment with a new kit.The blood volume in the kit was successfully returned to the patient by the instrument.No clots were reported to be visible.Update (b)(4) 2014: customer called back to report that the patient did complete a full treatment with a new kit from the same lot number with no further alarms, however the patient is currently in the icu for bleeding due to the amount of heparin the patient received from the photopheresis treatments.During the first treatment, the patient received (b)(4)units of heparin (a/c ratio set to 10:1) and during the second treatment, the patient received (b)(4) units of heparin (a/c ratio set to 8:1); using (b)(4) units of heparin in a 500ml bag of normal saline and the patient's platelet count was (b)(4).Customer stated that no clotting was found in the second kit used, the patient had a vortex port used in single needle mode.Css will follow up with the customer next week regarding this patient's next photopheresis treatment.Update (b)(4) 2014: css left two (2) messages for customer to return phone call.Customer called back and informed css that she has not had any updates on the patient, just that ecp is on hold for this patient.No product was returned for investigation.

Manufacturer Narrative

Batch record review of lot c710 was conducted.There were no non conformances associated with this lot, lot met lease requirements.Trends have been reviewed for this complaint category and no trend has been detected for any lot.The assessment is based on info available at the time of the investigation.No product was returned by customer for investigation; therefore, a definite root cause could not be determined at this time.Several attempts are being made to obtain more details related to the bleeding.If any further info is obtained a supplemental report will be created accordingly.(b)(4).

• Brand Name: THERAKOS UVAR XTS SYSTEM
• Type of Device: XTS
• Manufacturer (Section D): THERAKOS, INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey avenue; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 east; ste 140; bridgewater, NJ 08807
• MDR Report Key: 3763337
• MDR Text Key: 4550084
• Report Number: 2523595-2014-00093
• 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: 04/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 04/10/2014
• Initial Date FDA Received: 04/16/2014
• 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): Hospitalization; Life Threatening
• Patient Age: 67 YR
• Patient Weight: 70