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

Lot Number D312-KIT

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Vomiting (2144); Patient Problem/Medical Problem (2688)

Event Date 02/03/2016

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot d312 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.The uvadex lot number was not provided as it was not administered.However, a review of all uvadex lots manufactured since january 2013 was performed.No trends or nonconformances related to the complaint were noted.Trends were reviewed for complaint categories, hypotension, alarm #19: fluid balance limit and vomiting.No trends were detected for these complaint categories.An internal medical assessment was performed based on the information provided by the customer.The system was used for treatment of disease.From uvadex perspective, there was no evidence to suggest a causal relationship between the drug and the adverse event as it was not administered.The patient's hypotensive episode occurred prior to the administration of uvadex and the treatment was ended immediately after the hypotensive episode.This case was serious, unrelated and unexpected to uvadex.This was 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 was no device malfunction.Since the hypotensive eposide occurred during treatment and medical intervention with fluids was needed, and the patient was also hospitalized.This case was reportable as an 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.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, vomiting- 10021097, 10047700.(b)(4).

Event Description

The customer called to report that a patient had become hypotensive during a procedure.The customer said she received an alarm #19: fluid balance limit alarm.The customer reported that the patient's fluid balance parameters were set to +/- 350ml.The customer changed the fluid balance setting to -400ml, in order to clear the alarm.The customer ended the treatment and returned all fluids to the patient.The customer stated that the patient received a fluid bolus via an iv pump, and that the patient was then transferred to the er in order to stabilize further.The customer reported that the patient was put in trendelenburg's position, and that the patient remained conscious during the hypotensive episode.The customer stated that the patient has had approximately 20 photopheresis procedures.The customer reported that 15 of these procedures were blood primes and 5 were non-blood primes.The customer stated that this procedure was a single needle mode non-blood prime procedure.On (b)(6) 2016, the customer reported that the patient vomited once near the beginning of his hypotensive episode prior to his transfer to the er.The customer also stated that the patient was given 840ml of normal saline plus the return of his fluids from the instrument due to his hypotensive episode.The customer reported on (b)(6) 2016, that the patient was admitted to the hospital from the er for observation on (b)(6) 2016.The customer stated that the patient was in stable condition at the time.On (b)(6) 2016, the customer stated that the patient was discharged from the hospital on (b)(6) 2016 in stable condition.The kit was not returned for investigation.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• 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: 5466820
• MDR Text Key: 39249185
• Report Number: 2523595-2016-00047
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/03/2016

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: 03/01/2017
• Device Lot Number: D312-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2016
• Initial Date FDA Received: 02/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 9 YR
• Patient Weight: 29