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

Lot Number C909-KIT

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

Patient Problems Fainting (1847); Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418); Patient Problem/Medical Problem (2688)

Event Date 03/02/2016

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot c909 was conducted.There were no nonconformance associated with this lot.The lot met release requirements.The (b)(4) lot number was not provided as it was not administered.However, a review of all (b)(4) lots manufactured since january 2013 was performed.No trends or nonconformances related to the complaint were noted.Trends were reviewed for complaint categories, hypotension and fainting.No trends were detected for these complaint categories.The patient's hypotensive epsiode occurred prior to the administration of uvadex and the treatment was ended immediately after the hypostensive epsiode.This is not reportable from a drug perspective.From a device perspective, there was no device malfunction.Since the hypotensive epsiode occurred during treatment and medical intervention with saline was needed, this case is reportable as a mdr.The assessment is based on information available at the time of the investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.Based on the complaint description this issue was due to use error.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted through the capa/continuous improvement process.Adverse event term: hypotension, fainting.(b)(4).

Event Description

During a follow up call, the customer reported an adverse event in a procedure that occurred the day before.The customer stated that after an aborted treatment due to a leak centrifuge alarm and an occlusion system alarm, they started another treatment for this patient on a different instrument.Despite previously discussing with the customer that since +/- 400ml of whole blood was not returned to the patient due to the previously aborted treatment, close monitoring was necessary.However, the customer chose to treat the patient once again with a large centrifuge kit.The customer stated that she realized too late that this was not a good decision.The customer reported that in the second cycle the patient started to feel unwell and exhibited symptoms of hypovolemia and low blood pressure.The customer stated that the patient became unconscious for a few seconds.The customer reported that the patient quickly recovered.The treatment was aborted with no blood/product returned to the patient.The customer stated that the blood was not returned to the patient due to the fact that the patient's access was lost.The customer reported that the patient received 1000ml of 0.9% nacl via a very small canula.The customer was advised to always try to return the remaining blood to the patient, even at slow rates with a small canula.The customer stated that the patient was currently in another four cycle treatment with a small centrifuge kit.The customer reported that the patient was doing well and was in stable condition.The kit was not returned for investigation.Since the patient's hypotensive epsiode occurred during treatment and medical intervention with saline was needed, this case is reportable as a mdr even though there was no device malfuntion.

• Brand Name: THERAKOS XTS PHOTOPHERESIS SYSTEM
• Type of Device: XTS
• Manufacturer (Section D): THERAKOS, INC; hampton NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey ave; buffalo NY 14211
• Manufacturer Contact: megan vernak ; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 5527301
• MDR Text Key: 41208024
• Report Number: 2523595-2016-00082
• Device Sequence Number: 1
• Product Code: LNR
• 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
• Report Date: 03/03/2016

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: 11/01/2019
• Device Lot Number: C909-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2016
• Initial Date FDA Received: 03/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• 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 Age: 76 YR
• Patient Weight: 79