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

Lot Number D714-KIT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Diarrhea (1811); Nausea (1970); Pain (1994)

Event Date 11/24/2015

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot d714 was conducted.There were no non-conformances associated with this lot.The lot met release requirements.Uvadex lot# ad1436 was reviewed.No trends related to the complaint or nonconformances related to the complaint were noted.Trends were reviewed for complaint categories, occlusion system alarm, nausea, diarrhea or pain unspecified and no trends were detected.Based on the internal medical assessment this is an elderly female patient with lung transplant rejection.From a uvadex perspective, there is no evidence to suggest a causal relationship between the drug and the adverse event.This case is serious, unrelated and unexpected to uvadex.This is not reportable from a drug perspective.From a device perspective this event did not cause or contributed to a death or serious injury; and or the system did not cause or contributed to a death or serious injury nor malfunction in a way that would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur.There is no device malfunction.The ae was likely related to the ac and saline bags being spiked incorrectly.Medical intervention of paspertin was given.Hence, this case is reportable as an mdr.This assessment is based on information available at the time of the investigation.No product was returned by the customer for investigation; therefore, it could not be determined if this specific product met specification.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted through the capa/continuous improvement process.(b)(4).Device not returned to the manufacturer.

Event Description

During cellex operator training, therakos clinical services specialist (css) was asked for support in a treatment on the uvar xts.The operator reported system occlusion alarm during buffy coat collection in the first cycle.During troubleshooting css become aware that operator had connected the anticoagulant to the saline line and the saline to the anticoagulant line.Css advised to abort treatment without returning the volume to the patient.The treatment was aborted.The operator installed a new kit and started a new patient treatment.During the first cycle of the second treatment the patient was found with orthostatic hypotension, blood pressure of 45/33mmhg and a heart rate of 90/min.The patient complained of nausea and diarrhea.Treatment was aborted and as per physician instruction the patient received a 500ml saline bolus and one vial paspertin (metoclopramid) for nausea.The patient received 2 units of packed red blood cells after the treatment.Css suggested to check patients laboratory values after the aborted treatment and to consider to provide the patient with rbc transfusion because of low hct values.The responsible physician was informed.Css reviewed the extracorporeal blood volume (ecv) calculation and discussed to management of the patient with a maximum ecv of not more than 10% of total blood volume (tbv) due to patients general condition.No kit will be returned for investigation.

Manufacturer Narrative

The first ecp treatment was aborted due to user error (swapping ac and saline lines).The next treatment on the same day, patient developed hypotension due to fluid shift imbalance.500 ml of saline and a vial of paspertin were given to the patient along with two units of blood.Since medical intervention was given, this case is reportable as an mdr.(b)(4).(b)(6) 2016.Device not returned to the manufacturer.

• Brand Name: THERAKOS XTS PHOTOPHERESIS SYSTEM
• Type of Device: XTS
• Manufacturer (Section D): THERAKOS, INC.; west chester PA
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey ave.; buffalo NY 14211
• Manufacturer Contact: dianna inguanzo ; 10 north high street; suite 300; west chester, PA 19380
• MDR Report Key: 5317933
• MDR Text Key: 34115174
• Report Number: 2523595-2015-00298
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100016
• UDI-Public: 10705030100016
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/24/2015

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: Nurse
• Device Expiration Date: 04/01/2020
• Device Lot Number: D714-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2015
• Initial Date FDA Received: 12/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/06/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2015
• 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: 72