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

Lot Number B734-KIT

Device Problems Leak/Splash (1354); Device Displays Incorrect Message (2591)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 09/17/2014

Event Type  malfunction  

Event Description

The customer reported a leak at the hematocrit cuvette during collection in the fifth cycle.A blood pump error alarm occurred and the leak was noticed.The treatment was aborted and no blood was returned to the patient.The patient was stable during the procedure.The nurse reported high blood pressure after the procedure.A clinical services specialist called back to see if the patient's blood pressure had stabilized.The patient's blood pressure was still high, but the patient said she forgot to take her anti-hypertensive medication that day.No extra investigations were planned.On (b)(6) 2014, a clinical services specialist called back regarding the patient.The patients blood pressure was between 180 and 165 during the night.On the morning of (b)(6) 2014, the patient's blood pressure was 149 before her second ecp treatment.The patient told the nurse that her general practitioner has planned a holter ecg in the near future (unrelated to these ecp treatments).As of (b)(6) 2014 it was reported by the nurse that the patient was doing well after her second ecp treatment on (b)(6) 2014 and the patient returned home as planned.The patient plans further follow up with her general practitioner regarding her hypertension.On (b)(6) 2014, the responsible physician stated that the patient already had high blood pressure when she came for her first ecp treatment, and he would not relate the patient's high blood pressure to the ecp treatment.The patient spent two days, as planned, in the hospital in order to receive her ecp treatments, since this is customary for all ecp treatments.The patient was not hospitalized any longer than was planned.The kit was discarded and no pictures were taken.The customer will send the data key for evaluation.A damaged envelope was received by the manufacturer on 09/29/2014 from the customer however the data key was not inside the envelope.Thus no evaluation can be conducted.No service order was generated.

Manufacturer Narrative

Batch record review of lot b734 was conducted.There were no nonconformances associated with this lot.The lot met all release requirements.Trends were reviewed for complaint categories, hypertension, tubing leak, and blood pump error alarm.No trend was detected for complaint categories, hypertension, tubing leak, and blood pump error alarm.No capas were initiated for complaint categories, tubing leak and blood pump error alarm.Based on the medical assessment the patient's hypertension is most likely due to the patient not taking her anti-hypertensive medication.Hypertension is not related to ecp therapy.This case is reportable due to the tubing leak and not due to the patient's hypertension.The data key was to be sent to the manufacturer for evaluation; however a damaged envelope with no date key inside was received by the manufacturer.Thus no evaluation can be conducted.Complaints of this nature are monitored through tracking and trending.Should a trend arise further action will be taken.(b)(4).

• Brand Name: THERAKOS XTS PHOTOPHERESIS SYSTEM
• Type of Device: XTS
• 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 Key: 4152309
• MDR Text Key: 4915727
• Report Number: 2523595-2014-00261
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P680003
• 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: 09/17/2014

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: 11/01/2018
• Device Lot Number: B734-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/17/2014
• Initial Date FDA Received: 10/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 80