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

Lot Number C736-KIT

Device Problems Excess Flow or Over-Infusion (1311); Misassembled (1398); Device Displays Incorrect Message (2591)

Patient Problems Abdominal Pain (1685); Fatigue (1849); Skin Discoloration (2074); Tachycardia (2095)

Event Date 11/19/2014

Event Type  malfunction  

Event Description

The customer called a clinical services specialist on (b)(6) 2014, regarding a treatment that had been done on (b)(6) 2014, at about 4 pm.The customer stated that the tubing connections to the two right side ports of the fluid logic module were reversed.This resulted in the treatment volume from cycle 1 being sent directly to the recirculation bag, instead of being sent through the hematocrit sensor and into the photoactivation module.The customer stated this had not been discovered until the treatment volume had reached 205 ml.The customer stated the treatment volume was expected to be about 150 ml, not 205 ml.The customer stated there was no buffy volume exceeded alarm.The customer stated she decided not to continue the treatment when this was discovered.The customer stated she selected the "end treatment" option, but a blood pump error alarm occurred that could not be resolved.The operator then selected the "abort treatment" option, in order to complete a manual return of the patient's blood from the disposable kit to the patient.The customer reported that the patient's hematocrit had been 37.3 before starting the treatment, and the patient had been given a planned transfusion of 220 ml packed red blood cells prior to starting the ecp treatment, in order to increase her hematocrit for the ecp treatment.Customer reported the patient's hematocrit was 50.6 immediately after the manual return was completed, and 41.8 at 7 am the following morning.The customer stated the patient had a belly ache before starting the treatment, and the belly pain had increased by the end of the manual return.The customer reported that the belly pain was not related to the ecp treatment, but was related to a possible obstruction which is believed to be the cause of the patient's tachycardia before starting the ecp treatment.The customer reported the patient was unexpectedly admitted to hospital for the belly pain after the manual return was completed.The customer reported being concerned about the patient's extracorporeal volume.The customer stated the patient exhibited increased tachycardia, very slight pallor, and slightly increased lethargy, as the manual blood return was being administered.The customer stated the blood was successfully returned to the patient via manual return, and that the patient had regained equilibrium.The kit and pictures were returned for evaluation.No service order was generated.

Manufacturer Narrative

A batch review of lot c736 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.Trends were reviewed for complaint categories, damaged part/components, blood pump error alarm, and feeling abnormal.No trends were detected for any of these complaint categories.Blood pump error alarm was investigated through capa (b)(4).Capa (b)(4) was closed.Product return analysis feedback: the evaluation of the returned kit at the manufacturer confirmed the tubing lines were bonded to the incorrect ports.The cause for this complaint is operator error.The incident occurred when these tubes were not placed into the comb, but instead both lines were placed on the template without being snapped into the comb.This resulted in the tubing lines being routed to the incorrect cassette locations.Another possibility could have been reversing the placement of the two tubes within the comb.The corrective action to verify the proper assembly at the leak tester station is that black tape was added to the leak tester to clearly identify that the hematocrit is to be bonded to port #9.The clear plate tubing is then bonded into port #10.Additionally (b)(4) was opened to review the process and make recommendation to improve the reliability of the assembly station to prevent reverse tubing issue in future.Complaints of this nature are monitored through tracking and trending.(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 bailey ave.; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 east; suite 140; bridgewater, NJ 08807
• MDR Report Key: 4339973
• MDR Text Key: 20754522
• Report Number: 2523595-2014-00314
• 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: 11/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2019
• Device Lot Number: C736-KIT
• Other Device ID Number: 10705030100016
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/01/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• 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; Required Intervention
• Patient Age: 6 YR
• Patient Weight: 19