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

Lot Number D326-KIT

Device Problem Insufficient Information (3190)

Patient Problems Vomiting (2144); Hot Flashes/Flushes (2153); Pallor (2468); Ambulation Difficulties (2544)

Event Date 08/12/2015

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot d326 was conducted.There were no nonconformances associated with this lot.The lot met release requirements.Uvadex lot# ad1437 was reviewed.No trends or nonconformances related to the complaint were noted.Trends were reviewed for complaint categories, vomiting and vasovagal reaction.No trends were detected for these complaint categories.No corrective and preventive action was initiated for complaint categories, vomiting and vasovagal reaction.Based on the internal medical assessment, a male child patient with a hct before treatment of 25.9% had an adverse event during the buffy coat phase of the treatment.The patient had a blood prime.The patient stood up to go to the bathroom, and the nurses noted palor, vomiting, and unsteadiness.The patient was brought back to the bed and given 100ml saline bolus through the instrument followed by additional cells from the return bag.The treatment was completed, and the cells were returned to the patient post photoactivation.The customer called back to state that the patient had gotten up abruptly from sleep to have a large bowel movement.The patient complained of feeling hot while in the bathroom.The patient received an unplanned transfusion of additional volume from the return bag (blood prime unit transfusion) for symptom management.The patient returned to baseline within 5 minutes of onset.The system was used for treatment of disease.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.Uvadex was not administered when the adverse event occured.This is not reportable from a drug perspective.From a device perspective this event did not cause or contribute to a death or serious injury; and or the system did not cause or contribute to a death or serious injury nor malfunctioned 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.The adverse event was related to the fluid shift which is normal during the ecp procedure.The patient's underlying condition did not allow them to tolerate the fluid shift which caused the customer to provide intervention and give both a saline bolus and transfusion to the patient.Therefore, this is 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.(b)(4).

Event Description

The customer mentioned that a patient had an adverse event during the buffy coat phase of the treatment.The blood prime procedure utilized the patient's ecv during buffy coat collection.The patient stood up to go to the bathroom, and the nurses noted palor, vomiting, and unsteadiness.The patient was brought back to the bed and was given 100ml saline bolus through the instrument followed by additional cells from the return bag.The treatment was completed, and the cells were returned to the patient post photoactivation.On (b)(6) 2015, the customer called back to state that the patient got up abruptly from sleep to have a large bowel movement.The patient complained of feeling hot while in the bathroom.The patient received an unplanned transfusion of additional volume from the return bag (blood prime unit transfusion) for symptom management.The patient returned to baseline within five minutes of onset.The patient was reported to be in stable condition.No product was returned for evaluation.

Manufacturer Narrative

On (b)(6) 2015, the customer stated that the instrument serial number was (b)(4).(b)(4).Device not returned to manufacturer.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• 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: 5032474
• MDR Text Key: 24138633
• Report Number: 2523595-2015-00229
• 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
• Report Date: 08/13/2015

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: 05/01/2017
• Device Lot Number: D326-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2015
• 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 Age: 8 YR
• Patient Weight: 24